Trial · NCT00677833
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
NCT00677833, Phase 2, Phase 3, Completed, Pfizer; results first posted 2014-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa. Trials, record NCT00677833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00677833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
- NCT number
- NCT00677833
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Malaria, Falciparum
- Interventions
- Azithromycin plus Chloroquine, Artemether-lumefantrine
- First posted
- 2008-05-15
- Last updated
- 2014-06-26
- Results first posted
- 2014-06-26
- Limitations and caveats
- Cohort 1 was a screening cohort, meant for safety evaluation, but not included in the efficacy assessments.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | Day 28 | ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures \[LCF\] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Primary | Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | Day 28 | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With PCR-corrected ACPR in the mITT Population | Days 7, 14, 21, 35, 42 | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With PCR-corrected ACPR in PP Population | Days 7, 14, 21, 35, 42 | ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With PCR-uncorrected ACPR in the mITT Population | Days 7, 14, 21, 28, 35, 42 | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. |
| Secondary | Percentage of Participants With PCR-uncorrected ACPR in PP Population | Days 7, 14, 21, 28, 35, 42 | ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection. |
| Secondary | Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected) | Day 0 up to Day 3 | ETF defined as participants who met the following criteria: 1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia 2. Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature. 3. Parasitemia (P. falciparum) on Day 3 with fever or 4. Last available P. falciparum parasite count on Day 3 \>=25% of the first available parasite count on Day 0 (Baseline). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With ETF in PP Population (PCR-corrected) | Day 0 up to Day 3 | ETF defined as participants who met the following criteria: 1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia 2. Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature. 3. Parasitemia (P.falciparum) on Day 3 with fever or 4. Last available P.falciparum parasite count on Day 3 \>=25% of the first available parasite count on Day 0 (Baseline). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) | Days 7, 14, 21, 28, 35, 42 | LCF included participants who met any of the following criteria: 1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) 2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
| Secondary | Percentage of Participants With LCF in PP Population (PCR-corrected) | Days 7, 14, 21, 28, 35, 42 | LCF included participants who met any of the following criteria: 1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) 2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | Day 28 | mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter \[mcL\];fever/history of fever \>=38 degree Celsius\[C\] \[rectal\],37.2 degree C \[axillary\] or \>=37.5 degree C \[oral\] within last 24 hours).Participants in Ivory Coast center excluded from analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | Day 28 | Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PCR-corrected ACPR in the mITT Population | Days 7, 14, 21, 35, 42 | mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PCR-corrected ACPR in PP Population | Days 7, 14, 21, 35, 42 | PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PCR-uncorrected ACPR in the mITT Population | Days 7, 14, 21, 28, 35, 42 | mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PCR-uncorrected ACPR in PP Population | Days 7, 14, 21, 28, 35, 42 | PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected) | Day 0 up to Day 3 | mITT population, participants in Ivory Coast center were excluded from mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ETF in PP Population (PCR-corrected) | Day 0 up to Day 3 | PP population, participants in Ivory Coast center were excluded from the PP population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) | Days 7, 14, 21, 28, 35, 42 | mITT population, participants in Ivory Coast center were excluded from mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With LCF in PP Population (PCR-corrected) | Days 7, 14, 21, 28, 35, 42 | PP population, participants in Ivory Coast center were excluded from the PP population. | Percentage of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | Cohort 2: Azithromycin + Chloroquine | 89.27 | 95% Confidence Interval 82.77 to 95.77 | Percentage of participants | |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population | Cohort 2: Artemether + Lumefantrine | 98.37 | 95% Confidence Interval 95.59 to 100.00 | Percentage of participants | |
| Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | Cohort 2: Azithromycin + Chloroquine | 93.08 | 95% Confidence Interval 87.32 to 98.84 | Percentage of participants | |
| Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population | Cohort 2: Artemether + Lumefantrine | 99.16 | 95% Confidence Interval 96.97 to 100.00 | Percentage of participants | |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Azithromycin + Chloroquine | Day 7 | 94.17 | 95% Confidence Interval 89.55 to 98.78 | Percentage of participants |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Artemether + Lumefantrine | Day 7 | 99.21 | 95% Confidence Interval 97.25 to 100.00 | Percentage of participants |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Azithromycin + Chloroquine | Day 14 | 92.47 | 95% Confidence Interval 87.30 to 97.64 | Percentage of participants |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Artemether + Lumefantrine | Day 14 | 99.21 | 95% Confidence Interval 97.24 to 100.00 | Percentage of participants |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Azithromycin + Chloroquine | Day 21 | 91.59 | 95% Confidence Interval 86.04 to 97.14 | Percentage of participants |
| Percentage of Participants With PCR-corrected ACPR in the mITT Population | Cohort 2: Artemether + Lumefantrine | Day 21 | 98.37 | 95% Confidence Interval 95.65 to 100.00 | Percentage of participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Azithromycin + Chloroquine | 55 | |
| Overall Study | STARTED | Cohort 1: Artemether + Lumefantrine | 51 | |
| Overall Study | STARTED | Cohort 2: Azithromycin + Chloroquine | 124 | |
| Overall Study | STARTED | Cohort 2: Artemether + Lumefantrine | 131 | |
| Overall Study | COMPLETED | Cohort 1: Azithromycin + Chloroquine | 51 | |
| Overall Study | COMPLETED | Cohort 1: Artemether + Lumefantrine | 51 | |
| Overall Study | COMPLETED | Cohort 2: Azithromycin + Chloroquine | 122 | |
| Overall Study | COMPLETED | Cohort 2: Artemether + Lumefantrine | 128 | |
| Overall Study | NOT COMPLETED | Cohort 1: Azithromycin + Chloroquine | 4 | |
| Overall Study | NOT COMPLETED | Cohort 1: Artemether + Lumefantrine | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events408
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1: Azithromycin + Chloroquine | 0 | 55 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Artemether + Lumefantrine | 1 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Azithromycin + Chloroquine | 2 | 124 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Artemether + Lumefantrine | 4 | 131 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 1: Azithromycin + Chloroquine | 0 | 55 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 1: Artemether + Lumefantrine | 1 | 51 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 2: Azithromycin + Chloroquine | 1 | 124 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 2: Artemether + Lumefantrine | 0 | 131 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Cohort 1: Azithromycin + Chloroquine | 0 | 55 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Cohort 1: Artemether + Lumefantrine | 3 | 51 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Azithromycin + Chloroquine | ||
| Total, all-cause mortality | Cohort 1: Artemether + Lumefantrine | ||
| Total, all-cause mortality | Cohort 2: Azithromycin + Chloroquine | ||
| Total, all-cause mortality | Cohort 2: Artemether + Lumefantrine | ||
| Total, other adverse events | Cohort 1: Azithromycin + Chloroquine | 40 | 55 |
| Total, other adverse events | Cohort 1: Artemether + Lumefantrine | 36 | 51 |
| Total, other adverse events | Cohort 2: Azithromycin + Chloroquine | 103 | 124 |
| Total, other adverse events | Cohort 2: Artemether + Lumefantrine | 99 | 131 |
| Total, serious adverse events | Cohort 1: Azithromycin + Chloroquine | 1 | 55 |
| Total, serious adverse events | Cohort 1: Artemether + Lumefantrine | 2 | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25881046 | 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 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.
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Read this trial from software.
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