Trial Outcomes & Findings for Auranofin for Giardia Protozoa (NCT NCT02736968)
NCT ID: NCT02736968
Last Updated: 2023-01-26
Results Overview
Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Day 5
Results posted on
2023-01-26
Participant Flow
Participants were males and non-pregnant females between 18 to 65 years of age, inclusive, with amebiasis or giardiasis. Asymptomatic participants were recruited from the Mirpur community of Bangladesh by a randomized census. Symptomatic participants were identified by a health professional at either icddr,b or Rajshahi Medical College hospitals. Asymptomatic participants were enrolled from 06NOV2016 to 23APR2017. Symptomatic participants were enrolled from 16JAN2018 to 28JAN2021.
Participant milestones
| Measure |
Asymptomatic E. Histolytica- Auranofin
6mg auranofin daily x 7 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Asymptomatic E. Histolytica- Placebo
6mg placebo daily x 7 days
Placebo: Placebo
|
Asymptomatic Giardia- Auranofin
6mg auranofin daily x 5 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Asymptomatic Giardia- Placebo
6mg placebo daily x 5 days
Placebo: Placebo
|
Symptomatic E. Histolytica- Auranofin
6mg auranofin daily x 7 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Symptomatic E. Histolytica- Placebo
6mg placebo daily x 7 days
Placebo: Placebo
|
Symptomatic Giardia- Auranofin
6mg auranofin daily x 5 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Symptomatic Giardia- Placebo
6mg placebo daily x 5 days
Placebo: Placebo
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
17
|
16
|
0
|
0
|
30
|
29
|
|
Overall Study
COMPLETED
|
0
|
1
|
17
|
16
|
0
|
0
|
22
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
2
|
Reasons for withdrawal
| Measure |
Asymptomatic E. Histolytica- Auranofin
6mg auranofin daily x 7 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Asymptomatic E. Histolytica- Placebo
6mg placebo daily x 7 days
Placebo: Placebo
|
Asymptomatic Giardia- Auranofin
6mg auranofin daily x 5 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Asymptomatic Giardia- Placebo
6mg placebo daily x 5 days
Placebo: Placebo
|
Symptomatic E. Histolytica- Auranofin
6mg auranofin daily x 7 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Symptomatic E. Histolytica- Placebo
6mg placebo daily x 7 days
Placebo: Placebo
|
Symptomatic Giardia- Auranofin
6mg auranofin daily x 5 days
Auranofin: Auranofin is a gold-containing chemical salt available as 3mg capsules
|
Symptomatic Giardia- Placebo
6mg placebo daily x 5 days
Placebo: Placebo
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
2
|
|
Overall Study
COVID-19 Pandemic
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Auranofin for Giardia Protozoa
Baseline characteristics by cohort
| Measure |
Asymptomatic E. Histolytica- Placebo
n=1 Participants
6mg placebo daily x 7 days
|
Asymptomatic Giardia- Auranofin
n=17 Participants
6mg auranofin daily x 5 days
|
Asymptomatic Giardia- Placebo
n=16 Participants
6mg placebo daily x 5 days
|
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 0 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
33.4 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
34.6 years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Bangladesh
|
1 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
30 participants
n=4 Participants
|
29 participants
n=21 Participants
|
93 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: Modified Intention to Treat Population: All symptomatic participants who were randomized with available results, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=29 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia and Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours)
|
28 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Day 5. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=14 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=14 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Number of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test)
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 3 through Day 5Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 3 and 5. Stool samples were tested for Giardia using antigen detection EIA. Proportions are calculated as the number of participants with negative Giardia stool antigen tests divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Participants With Negative Giardia Stool Antigens
Day 3
|
0.45 proportion of participants
Interval 0.28 to 0.62
|
0.38 proportion of participants
Interval 0.23 to 0.56
|
|
Proportion of Participants With Negative Giardia Stool Antigens
Day 5
|
0.55 proportion of participants
Interval 0.38 to 0.72
|
0.34 proportion of participants
Interval 0.2 to 0.53
|
SECONDARY outcome
Timeframe: Day 3 through Day 5Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 3 and 5. Stool samples were assessed for parasitological response by detection of trophozoites via microscopic exam. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response
Day 3
|
0.97 proportion of participants
Interval 0.81 to 1.0
|
0.93 proportion of participants
Interval 0.77 to 0.99
|
|
Proportion of Symptomatic Participants With Positive Rapid EIA and Positive Antigen Detection EIA for Giardia and Trophozoites on Smear at Enrollment With Parasitological Response
Day 5
|
0.97 proportion of participants
Interval 0.81 to 1.0
|
1.00 proportion of participants
Interval 0.86 to 1.0
|
SECONDARY outcome
Timeframe: Day 14 through Day 28Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of trophozoites via microscopic exam. Proportion is calculated as the number of participants with sustained cure divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Symptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam)
Day 14
|
0.96 proportion of participants
Interval 0.81 to 1.0
|
0.90 proportion of participants
Interval 0.73 to 0.97
|
|
Proportion of Symptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam)
Day 28
|
0.96 proportion of participants
Interval 0.78 to 1.0
|
0.89 proportion of participants
Interval 0.72 to 0.97
|
SECONDARY outcome
Timeframe: Day 3 through Day 5Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment, with available results.
Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR).
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools of Symptomatic Participants
Day 3
|
8.6 log parasite load/uL
Interval 7.1 to 10.1
|
9.2 log parasite load/uL
Interval 8.0 to 10.4
|
|
Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools of Symptomatic Participants
Day 5
|
8.2 log parasite load/uL
Interval 6.8 to 9.6
|
8.1 log parasite load/uL
Interval 7.1 to 9.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment, with available results.
Diarrhea was assessed by self-report at each study visit. Resolution of diarrhea occurred when participants reported less than 3 loose stools in 24 hours.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=29 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Time to Resolution of Diarrhea (Less Than 3 Loose Stools/24 Hours)
|
3 days
Interval 3.0 to 4.0
|
3 days
Not calculable due to low sample size and participants resolving at day 3.
|
SECONDARY outcome
Timeframe: Day 3Population: Modified Intention to Treat Population: All participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Day3. Stool samples were assessed for parasitological response by detection of cysts or trophozoites via microscopic exam or a negative antigen test. Proportions are calculated as the number of participants with parasitological response divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=14 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=14 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Participants With Positive Rapid Enzyme Immunoassay (EIA) and Positive Antigen Detection EIA for Giardia at Enrollment With Parasitological Response (no Detection of Cysts or Trophozoites on Microscopic Exam or Negative Antigen Test)
|
0.43 proportion with parasitological response
Interval 0.21 to 0.67
|
0.29 proportion with parasitological response
Interval 0.11 to 0.55
|
SECONDARY outcome
Timeframe: Day 3 through Day 5Population: Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 3 and 5. The Giardia trophozoite/cyst load (parasites/uL) for each group was then assessed by Quantitative Polymerase Chain Reaction (qPCR).
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=14 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=14 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools
Day 3
|
7.5 log parasite load/uL
Interval 5.0 to 10.0
|
9.0 log parasite load/uL
Interval 6.8 to 11.2
|
|
Giardia Trophozoite/Cyst Load by Quantitative Polymerase Chain Reaction (qPCR) in Stools
Day 5
|
7.1 log parasite load/uL
Interval 4.9 to 9.2
|
8.5 log parasite load/uL
Interval 6.3 to 10.8
|
SECONDARY outcome
Timeframe: Day 14 through Day 28Population: Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 14 and 28. Stool samples were assessed for sustained Giardia cure by detection of cysts or trophozoites via microscopic exam or negative antigen detection. Proportions are calculated as the number of participants with sustained cure divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=14 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=14 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Asymptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam)
Day 28
|
0.29 proportion of participants
Interval 0.11 to 0.55
|
0.14 proportion of participants
Interval 0.03 to 0.41
|
|
Proportion of Asymptomatic Participants With Sustained Giardia Cure (no Detection of Trophozoites by Microscopic Exam)
Day 14
|
0.29 proportion of participants
Interval 0.11 to 0.55
|
0.21 proportion of participants
Interval 0.07 to 0.48
|
SECONDARY outcome
Timeframe: Day 14 through Day 28Population: Modified Intention to Treat Population: All asymptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 14 and 28. Any stool that was still positive for Giardia or trophozoites at Days 14 and 28 had DNA genotyping of the parasite performed on de-identified specimens of extracted DNA. The genotypes from initial and final isolates were compared to determine relapse and/or re-infection. Proportion is calculated as the number of participants with relapse or re-infection divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=14 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=14 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 14 - Relapse
|
0.58 proportion of participants
Interval 0.32 to 0.81
|
0.75 proportion of participants
Interval 0.46 to 0.92
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 14 - Re-infection
|
0.33 proportion of participants
Interval 0.14 to 0.61
|
0.25 proportion of participants
Interval 0.08 to 0.54
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 28 - Relapse
|
0.63 proportion of participants
Interval 0.3 to 0.87
|
0.73 proportion of participants
Interval 0.43 to 0.91
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 28 - Re-infection
|
0.25 proportion of participants
Interval 0.06 to 0.6
|
0.09 proportion of participants
Interval 0.0 to 0.4
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: Modified Intention to Treat Population: All symptomatic participants who were randomized, dispensed at least one dose of study medication, and had a positive rapid EIA and positive antigen detection EIA for Giardia at enrollment.
Participants provided stool samples on Days 1, 14 and 28. Participants that were positive for Giardia via antigen detection at Day 1 and had a negative antigen detection test followed by a positive antigen detection test had DNA genotyping of the parasite performed on de-identified specimens of extracted DNA. The genotypes from initial (Day 1) and final isolates (Day 14/28) were compared to determine relapse and/or re-infection. Proportion is calculated as the number of participants with relapse or re-infection divided by the number of participants with results available.
Outcome measures
| Measure |
Symptomatic Giardia- Auranofin
n=30 Participants
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 Participants
6mg placebo daily x 5 days
|
|---|---|---|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 14 - Relapse
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0.07 proportion of participants
Interval 0.0 to 0.32
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 14 - Re-infection
|
0.00 proportion of participants
Interval 0.0 to 0.28
|
0.07 proportion of participants
Interval 0.0 to 0.32
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 28 - Relapse
|
0.11 proportion of participants
Interval 0.0 to 0.46
|
0.07 proportion of participants
Interval 0.0 to 0.34
|
|
Proportion of Participants With Relapse (Same Strain) or Re-infection (New Strain) With Giardia-positive Stools by Genotyping the Initial vs. Subsequent Strain
Day 28 - Re-infection
|
0.00 proportion of participants
Interval 0.0 to 0.34
|
0.14 proportion of participants
Interval 0.03 to 0.41
|
Adverse Events
Asymptomatic E. Histolytica- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asymptomatic Giardia- Auranofin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Asymptomatic Giardia- Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Symptomatic Giardia- Auranofin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Symptomatic Giardia- Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asymptomatic E. Histolytica- Placebo
n=1 participants at risk
6mg placebo daily x 7 days
|
Asymptomatic Giardia- Auranofin
n=17 participants at risk
6mg auranofin daily x 5 days
|
Asymptomatic Giardia- Placebo
n=16 participants at risk
6mg placebo daily x 5 days
|
Symptomatic Giardia- Auranofin
n=30 participants at risk
6mg auranofin daily x 5 days
|
Symptomatic Giardia- Placebo
n=29 participants at risk
6mg placebo daily x 5 days
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Infections and infestations
Furuncle
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/17 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
12.5%
2/16 • Number of events 2 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/17 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/17 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
12.5%
2/16 • Number of events 2 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
17.6%
3/17 • Number of events 4 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
|
Infections and infestations
Abscess Rupture
|
0.00%
0/1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/16 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/30 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
0.00%
0/29 • Adverse events were collected from the time the participants received study product and continued through study day 29.
Adverse events were collected at each visit using specific questions and/or targeted physical examination. No adverse events were collected for the following groups due to no participants enrolled: Asymptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Auranofin, Symptomatic E. histolytica- Placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60