Trial · NCT02851108
Methylene Blue Against Falciparum Malaria in Burkina Faso
NCT02851108, Phase 2, Completed, Heidelberg University; results first posted 2020-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methylene Blue Against Falciparum Malaria in Burkina Faso. Trials, record NCT02851108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02851108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methylene Blue Against Falciparum Malaria in Burkina Faso
- NCT number
- NCT02851108
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Heidelberg University
- Conditions
- Malaria, Falciparum
- Interventions
- Methylene Blue, Primaquine
- First posted
- 2016-08-01
- Last updated
- 2020-03-25
- Results first posted
- 2020-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Haemoglobin Compared to the Baseline | 7 days | Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden) |
| Secondary | Gametocyte Prevalence | 28 days | measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up |
| Secondary | Adverse Events (AE) | 28 days | Reports of observed or self-reported adverse event |
| Secondary | Mothers/Caretakers Questionnaire on Acceptance | 14 days | Acceptance of the different treatment regimens by mothers/caretakers |
| Secondary | Gametocyte Density | 28 days | measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Haemoglobin Compared to the Baseline | 7 days | g/dl | MEAN | |
| SECONDARY | Gametocyte Prevalence | 28 days | |||
| SECONDARY | Adverse Events (AE) | 28 days | |||
| SECONDARY | Mothers/Caretakers Questionnaire on Acceptance | 14 days | |||
| SECONDARY | Gametocyte Density | 28 days |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Haemoglobin Compared to the Baseline | AS-AQ-MB | 0.18 | Standard Deviation 1.42 | g/dl | |
| Change in Haemoglobin Compared to the Baseline | AS-AQ-PQ | 0.54 | Standard Deviation 0.94 | g/dl |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AS-AQ-MB | 50 | |
| Overall Study | STARTED | AS-AQ-PQ | 50 | |
| Overall Study | COMPLETED | AS-AQ-MB | 42 | |
| Overall Study | COMPLETED | AS-AQ-PQ | 49 | |
| Overall Study | NOT COMPLETED | AS-AQ-MB | 8 | |
| Overall Study | NOT COMPLETED | AS-AQ-PQ | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastro-intestinal symptoms | Gastrointestinal disorders | AS-AQ-MB | 14 | 50 | 19 |
| other | Gastro-intestinal symptoms | Gastrointestinal disorders | AS-AQ-PQ | 13 | 50 | 16 |
| other | Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | AS-AQ-MB | 20 | 50 | 25 |
| other | Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | AS-AQ-PQ | 20 | 50 | 35 |
| serious | Severe anemia | Blood and lymphatic system disorders | AS-AQ-MB | 1 | 50 | 1 |
| serious | Severe anemia | Blood and lymphatic system disorders | AS-AQ-PQ | 0 | 50 | 0 |
| serious | Severe malaria | Infections and infestations | AS-AQ-MB | 1 | 50 | 1 |
| serious | Severe malaria | Infections and infestations | AS-AQ-PQ | 0 | 50 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AS-AQ-MB | ||
| Total, all-cause mortality | AS-AQ-PQ | ||
| Total, other adverse events | AS-AQ-MB | 33 | 50 |
| Total, other adverse events | AS-AQ-PQ | 28 | 50 |
| Total, serious adverse events | AS-AQ-MB | 2 | 50 |
| Total, serious adverse events | AS-AQ-PQ | 0 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31600221 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AS-AQ-MB vs AS-AQ-PQ: serious adverse events |
Source Trial comparisons
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/NCT02851108
GET https://conductscience.org/api/trials/v1/NCT02851108/registered