Trial Outcomes & Findings for Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis (NCT NCT01593722)
NCT ID: NCT01593722
Last Updated: 2016-11-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
155 participants
Primary outcome timeframe
7 days
Results posted on
2016-11-09
Participant Flow
Of the155 subjects recruited, 92 were eligible for screening and signed consent. Thirty had loiasis, of which 16 were excluded because their microfilarial counts were \>5000 mf/mL. One subject was excluded because of age and one declined to participate. The remaining 12 patients were enrolled in the treatment arm of the study.
Participant milestones
| Measure |
Single Dose DEC
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Single Dose IVM
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis
Baseline characteristics by cohort
| Measure |
Single Dose DEC
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
SIngle Dose IVM
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
n=5 Participants
|
38.5 years
n=7 Participants
|
44.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Cameroon
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Absolute eosinophil count
|
3.27 cells x 10^9/L
n=5 Participants
|
1.76 cells x 10^9/L
n=7 Participants
|
2.40 cells x 10^9/L
n=5 Participants
|
|
Loa microfilarial count
|
1074 mf/ml
n=5 Participants
|
355 mf/ml
n=7 Participants
|
618 mf/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Diethylcarbamazine
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.
|
196 percentage of baseline
Interval 112.0 to 224.0
|
165 percentage of baseline
Interval 124.0 to 257.0
|
SECONDARY outcome
Timeframe: 7 daysSymptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment
Outcome measures
| Measure |
Diethylcarbamazine
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
The Frequency of Adverse Events
|
115 events
|
103 events
|
SECONDARY outcome
Timeframe: 3 daysLevels of surface marker expression on eosinophils
Outcome measures
| Measure |
Diethylcarbamazine
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
Eosinophil Activation
%CD69 expression on eosinophils at baseline
|
1.7 % cells expressing CD69
Interval 0.1 to 4.2
|
1.5 % cells expressing CD69
Interval 0.1 to 4.6
|
|
Eosinophil Activation
%CD69 expression on eosinophils at peak
|
21.5 % cells expressing CD69
Interval 6.1 to 79.7
|
21.5 % cells expressing CD69
Interval 8.4 to 94.0
|
SECONDARY outcome
Timeframe: 14 daysOutcome measures
| Measure |
Diethylcarbamazine
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
Proportion of Subjects Who Clear Microfilaremia
|
3 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Microfilarial count and symptoms
Proportion of subjects without signs of infection
Outcome measures
| Measure |
Diethylcarbamazine
n=6 Participants
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 Participants
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
Treatment Efficacy
|
0 participants
|
1 participants
|
Adverse Events
Diethylcarbamazine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ivermectin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diethylcarbamazine
n=6 participants at risk
diethylcarbamazine 8 mg/kg single oral dose
Diethylcarbamazine: single dose
|
Ivermectin
n=6 participants at risk
ivermectin 200 mcg/kg single oral dose
Ivermectin: single dose
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Calabar swelling
|
50.0%
3/6
|
33.3%
2/6
|
|
Nervous system disorders
Headache
|
66.7%
4/6
|
66.7%
4/6
|
|
Infections and infestations
Eyeworm
|
16.7%
1/6
|
33.3%
2/6
|
|
Eye disorders
Blurry vision
|
50.0%
3/6
|
16.7%
1/6
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6
|
16.7%
1/6
|
|
Nervous system disorders
Dizziness
|
66.7%
4/6
|
33.3%
2/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia
|
33.3%
2/6
|
83.3%
5/6
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
50.0%
3/6
|
|
Gastrointestinal disorders
Nausea/vomiting
|
33.3%
2/6
|
33.3%
2/6
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6
|
33.3%
2/6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
50.0%
3/6
|
50.0%
3/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/6
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
3/6
|
66.7%
4/6
|
|
General disorders
Fatigue
|
33.3%
2/6
|
0.00%
0/6
|
Additional Information
Dr. Amy Klion
Laboratory of Parasitic Diseases, NIAID, NIH
Phone: 301-435-8903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place