Trial Outcomes & Findings for A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh (NCT NCT02389374)
NCT ID: NCT02389374
Last Updated: 2024-03-13
Results Overview
The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
during follow up (day 28)
Results posted on
2024-03-13
Participant Flow
Participant milestones
| Measure |
Chloroquine Primaquine 14days
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
115
|
11
|
|
Overall Study
COMPLETED
|
46
|
87
|
10
|
|
Overall Study
NOT COMPLETED
|
9
|
28
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
Baseline characteristics by cohort
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18 years
n=5 Participants
|
22 years
n=7 Participants
|
14 years
n=5 Participants
|
20 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Region of Enrollment
Bangladesh
|
55 participants
n=5 Participants
|
115 participants
n=7 Participants
|
11 participants
n=5 Participants
|
181 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during follow up (day 28)The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: day 28Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: day 0 and 16Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Fractional Change in Hb Between Baseline and Day 9 and 16
baseline to day 9
|
-2.3 percent change Hb
Interval -6.2 to 1.5
|
-7.7 percent change Hb
Interval -11.2 to -4.2
|
-13.8 percent change Hb
Interval -22.1 to -5.5
|
|
Fractional Change in Hb Between Baseline and Day 9 and 16
baseline to day 16
|
-0.5 percent change Hb
Interval -6.1 to 5.1
|
NA percent change Hb
No visit on day 16
|
-8.3 percent change Hb
Interval -20.2 to 3.7
|
SECONDARY outcome
Timeframe: on day 2Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Proportion of Patients With Anaemia Less Than 8g/dl on Day 2
|
0 participants with Hb under 8g/dl
|
2 participants with Hb under 8g/dl
|
0 participants with Hb under 8g/dl
|
SECONDARY outcome
Timeframe: day 3Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Proportion of Patients With Any Parasitemia on Day 3 After Treatment
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: day 2Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=112 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Proportion of Patients With Fever on Day 2 After Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 16Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=55 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=11 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Recurrence of Parasitaemia Within 16 Days of Follow up
|
0 Recurrences of Parsitaemia
|
0 Recurrences of Parsitaemia
|
0 Recurrences of Parsitaemia
|
SECONDARY outcome
Timeframe: day 16Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=43 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
n=115 Participants
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
n=9 Participants
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count
|
34 Participants
|
NA Participants
this outcome was only collected for the other two arms
|
7 Participants
|
SECONDARY outcome
Timeframe: day 0Outcome measures
| Measure |
Chloroquine Primaquine 14days
n=181 Participants
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
chloroquine: standard dose
Primaquine: 14 days
|
Artemether-lumefantrine Primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: single dose
|
Artemether-lumefantrine Primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
Artemether-lumefantrine combination: standard dose
Primaquine: 14 days
|
|---|---|---|---|
|
The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients
|
7.82 U/gHb
Interval 6.62 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: day 0 or 1Population: data were not collected
Frequency and type of variants of the G6PD gene within the study population
Outcome measures
Outcome data not reported
Adverse Events
Chloroquine Primaquine 14days
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artemether-lumefantrine Primaquine 1day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Artemether-lumefantrine Primaquine 14days
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place