Trial · NCT02389374
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
NCT02389374, Phase 4, Completed, Menzies School of Health Research; results first posted 2017-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh. Trials, record NCT02389374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02389374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh
- NCT number
- NCT02389374
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 181 participants, actual
- Lead sponsor
- Menzies School of Health Research
- Conditions
- Malaria
- Interventions
- chloroquine, Artemether-lumefantrine combination, Primaquine, Primaquine
- First posted
- 2015-03-17
- Last updated
- 2024-03-13
- Results first posted
- 2017-08-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | during follow up (day 28) | The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28 |
| Secondary | Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | day 28 | |
| Secondary | Fractional Change in Hb Between Baseline and Day 9 and 16 | day 0 and 16 | |
| Secondary | Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 | on day 2 | |
| Secondary | Proportion of Patients With Any Parasitemia on Day 3 After Treatment | day 3 | |
| Secondary | Proportion of Patients With Fever on Day 2 After Treatment | day 2 | |
| Secondary | Recurrence of Parasitaemia Within 16 Days of Follow up | day 16 | |
| Secondary | Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count | day 16 | |
| Secondary | The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients | day 0 | |
| Secondary | Frequency and Type of Variants of the G6PD Gene Within the Study Population | day 0 or 1 | Frequency and type of variants of the G6PD gene within the study population |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | during follow up (day 28) | events | NUMBER | |
| SECONDARY | Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | day 28 | participants | NUMBER | |
| SECONDARY | Fractional Change in Hb Between Baseline and Day 9 and 16 | day 0 and 16 | percent change Hb | MEAN | |
| SECONDARY | Proportion of Patients With Anaemia Less Than 8g/dl on Day 2 | on day 2 | participants with Hb under 8g/dl | NUMBER | |
| SECONDARY | Proportion of Patients With Any Parasitemia on Day 3 After Treatment | day 3 | participants | NUMBER | |
| SECONDARY | Proportion of Patients With Fever on Day 2 After Treatment | day 2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Recurrence of Parasitaemia Within 16 Days of Follow up | day 16 | Recurrences of Parsitaemia | NUMBER | |
| SECONDARY | Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count | day 16 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients | day 0 | U/gHb | MEDIAN | |
| SECONDARY | Frequency and Type of Variants of the G6PD Gene Within the Study Population | day 0 or 1 | data were not collected |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | Chloroquine Primaquine 14days | 0 | events | ||
| The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | Artemether-lumefantrine Primaquine 1day | 0 | events | ||
| The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment | Artemether-lumefantrine Primaquine 14days | 0 | events | ||
| Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | Chloroquine Primaquine 14days | 0 | participants | ||
| Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | Artemether-lumefantrine Primaquine 1day | 0 | participants | ||
| Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl) | Artemether-lumefantrine Primaquine 14days | 0 | participants | ||
| Fractional Change in Hb Between Baseline and Day 9 and 16 | Chloroquine Primaquine 14days | baseline to day 9 | -2.3 | 95% Confidence Interval -6.2 to 1.5 | percent change Hb |
| Fractional Change in Hb Between Baseline and Day 9 and 16 | Artemether-lumefantrine Primaquine 1day | baseline to day 9 | -7.7 | 95% Confidence Interval -11.2 to -4.2 | percent change Hb |
| Fractional Change in Hb Between Baseline and Day 9 and 16 | Artemether-lumefantrine Primaquine 14days | baseline to day 9 | -13.8 | 95% Confidence Interval -22.1 to -5.5 | percent change Hb |
| Fractional Change in Hb Between Baseline and Day 9 and 16 | Chloroquine Primaquine 14days | baseline to day 16 | -0.5 | 95% Confidence Interval -6.1 to 5.1 | percent change Hb |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chloroquine Primaquine 14days | 55 | |
| Overall Study | STARTED | Artemether-lumefantrine Primaquine 1day | 115 | |
| Overall Study | STARTED | Artemether-lumefantrine Primaquine 14days | 11 | |
| Overall Study | COMPLETED | Chloroquine Primaquine 14days | 46 | |
| Overall Study | COMPLETED | Artemether-lumefantrine Primaquine 1day | 87 | |
| Overall Study | COMPLETED | Artemether-lumefantrine Primaquine 14days | 10 | |
| Overall Study | NOT COMPLETED | Chloroquine Primaquine 14days | 9 | |
| Overall Study | NOT COMPLETED | Artemether-lumefantrine Primaquine 1day | 28 | |
| Overall Study | NOT COMPLETED | Artemether-lumefantrine Primaquine 14days | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chloroquine Primaquine 14days | ||
| Total, all-cause mortality | Artemether-lumefantrine Primaquine 1day | ||
| Total, all-cause mortality | Artemether-lumefantrine Primaquine 14days | ||
| Total, other adverse events | Chloroquine Primaquine 14days | 0 | 55 |
| Total, other adverse events | Artemether-lumefantrine Primaquine 1day | 0 | 115 |
| Total, other adverse events | Artemether-lumefantrine Primaquine 14days | 0 | 11 |
| Total, serious adverse events | Chloroquine Primaquine 14days | 0 | 55 |
| Total, serious adverse events | Artemether-lumefantrine Primaquine 1day | 0 | 115 |
| Total, serious adverse events | Artemether-lumefantrine Primaquine 14days | 0 | 11 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02389374
GET https://conductscience.org/api/trials/v1/NCT02389374/results?page=2