Trial · NCT00379821
Chloroquine Alone or in Combination for Malaria in Children in Malawi
NCT00379821, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2011-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chloroquine Alone or in Combination for Malaria in Children in Malawi. Trials, record NCT00379821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00379821
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chloroquine Alone or in Combination for Malaria in Children in Malawi
- NCT number
- NCT00379821
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 640 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Plasmodium Falciparum Infection
- Interventions
- Atovaquone-proguanil, Artesunate, Azithromycin, Chloroquine
- First posted
- 2006-09-25
- Last updated
- 2014-08-11
- Results first posted
- 2011-07-27
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Clinical Malaria Episodes Per Year of Follow-up | 1 year | Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR). |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of initial malaria episode (Episode 0) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of first subsequent malaria episode (Episode 1) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of second subsequent malaria episode (Episode 2) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of third subsequent malaria episode (Episode 3) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of fourth subsequent malaria episode (Episode 4) | Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure. |
| Secondary | Number of Cases of Severe Malaria in Each Treatment Arm | 1 Year | A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score \< 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis. |
| Secondary | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger. | 1 year | Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age. |
| Secondary | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age. | 1 year | Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age. |
| Secondary | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of initial malaria episode (Episode 0) | Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Clinical Malaria Episodes Per Year of Follow-up | 1 year | The intention to treat (ITT) population was used for the primary outcome. | Episodes per PYAR | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of initial malaria episode (Episode 0) | This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of first subsequent malaria episode (Episode 1) | This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of second subsequent malaria episode (Episode 2) | This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of third subsequent malaria episode (Episode 3) | This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode. | Participants | NUMBER |
| SECONDARY | Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Day 28 of fourth subsequent malaria episode (Episode 4) | This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode. | Participants | NUMBER |
| SECONDARY | Number of Cases of Severe Malaria in Each Treatment Arm | 1 Year | The safety cohort includes all participants. | Cases of severe malaria | NUMBER |
| SECONDARY | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger. | 1 year | The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit. | Grams/Deciliter | MEAN |
| SECONDARY | Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age. | 1 year | The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit. | Grams/Deciliter | MEAN |
| SECONDARY | Mean Creatinine in Each Treatment Arm (Renal Function) | Day 0 of initial malaria episode (Episode 0) | The safety population includes all participants who have laboratory results reported at the time point for the episode. | Micromole/Liter | MEAN |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group235
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Clinical Malaria Episodes Per Year of Follow-up | Chloroquine Plus Artesunate | 0.61 | Episodes per PYAR | ||
| Number of Clinical Malaria Episodes Per Year of Follow-up | Chloroquine Plus Atovaquone-Proguanil | 0.68 | Episodes per PYAR | ||
| Number of Clinical Malaria Episodes Per Year of Follow-up | CQ Plus Azithromycin | 0.64 | Episodes per PYAR | ||
| Number of Clinical Malaria Episodes Per Year of Follow-up | CQ Monotherapy | 0.59 | Episodes per PYAR | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Chloroquine Plus Artesunate | 143 | Participants | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Chloroquine Plus Atovaquone-Proguanil | 133 | Participants | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | CQ Plus Azithromycin | 137 | Participants | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | CQ Monotherapy | 135 | Participants | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Chloroquine Plus Artesunate | 46 | Participants | ||
| Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm | Chloroquine Plus Atovaquone-Proguanil | 42 | Participants |
1 to 10 of 235Source ClinicalTrials.gov
See all 235 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chloroquine Plus Artesunate | 160 | |
| Overall Study | STARTED | Chloroquine Plus Atovaquone-Proguanil | 160 | |
| Overall Study | STARTED | CQ Plus Azithromycin | 160 | |
| Overall Study | STARTED | CQ Monotherapy | 160 | |
| Overall Study | COMPLETED | Chloroquine Plus Artesunate | 87 | |
| Overall Study | COMPLETED | Chloroquine Plus Atovaquone-Proguanil | 71 | |
| Overall Study | COMPLETED | CQ Plus Azithromycin | 93 | |
| Overall Study | COMPLETED | CQ Monotherapy | 81 | |
| Overall Study | NOT COMPLETED | Chloroquine Plus Artesunate | 73 | |
| Overall Study | NOT COMPLETED | Chloroquine Plus Atovaquone-Proguanil | 89 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events216
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 | Haemorrhagic anaemia | Blood and lymphatic system disorders | Chloroquine Plus Artesunate | 26 | 160 | 32 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Chloroquine Plus Atovaquone-Proguanil | 28 | 160 | 32 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | CQ Plus Azithromycin | 32 | 160 | 36 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | CQ Monotherapy | 38 | 160 | 41 |
| other | Neutropenia | Blood and lymphatic system disorders | Chloroquine Plus Artesunate | 1 | 160 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Chloroquine Plus Atovaquone-Proguanil | 4 | 160 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | CQ Plus Azithromycin | 8 | 160 | 8 |
| other | Neutropenia | Blood and lymphatic system disorders | CQ Monotherapy | 1 | 160 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chloroquine Plus Artesunate | 11 | 160 | 11 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chloroquine Plus Atovaquone-Proguanil | 6 | 160 | 6 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chloroquine Plus Artesunate | ||
| Total, all-cause mortality | Chloroquine Plus Atovaquone-Proguanil | ||
| Total, all-cause mortality | CQ Plus Azithromycin | ||
| Total, all-cause mortality | CQ Monotherapy | ||
| Total, other adverse events | Chloroquine Plus Artesunate | 144 | 160 |
| Total, other adverse events | Chloroquine Plus Atovaquone-Proguanil | 140 | 160 |
| Total, other adverse events | CQ Plus Azithromycin | 143 | 160 |
| Total, other adverse events | CQ Monotherapy | 145 | 160 |
| Total, serious adverse events | Chloroquine Plus Artesunate | 8 | 160 |
| Total, serious adverse events | Chloroquine Plus Atovaquone-Proguanil | 14 | 160 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22912697 | BACKGROUND |
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 |
|---|
| Chloroquine Plus Atovaquone-Proguanil vs CQ Plus Azithromycin: Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm |
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/NCT00379821
GET https://conductscience.org/api/trials/v1/NCT00379821/registered?page=2