Malaria, FalciparumPhase 2/3NCT00677833
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
A Phase 2/3 study testing Azithromycin plus Chloroquine and Artemether-lumefantrine in people with Malaria, Falciparum, run by Pfizer at 7 sites in 5 countries.
Trial summary
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Azithromycin plus Chloroquine and Artemether-lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Jun 2008to Sep 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Girls and boys ≥5 years to ≤12 years (Cohort 1); and ≥6 to ≤59 months of age (Cohort 2) with uncomplicated, symptomatic malaria as indicated by the presence of the following:
- Blood smears positive for monoinfection with P. falciparum and asexual parasitemia between 1000 -100,000 parasites/µL;
- Documented fever (38.0°C/100.4°F rectal or tympanic; 37.2°C/99.0°F axillary or 37.5°C/99.5°F oral) or history of fever (as reported by the legally acceptable representative) within the prior 24 hours;
- Appropriate for outpatient treatment;
- Blood glucose ≥60 mg/dL;
- Hemoglobin ≥6 g/dl or hematocrit ≥18% without signs of anemia-induced Congestive Heart Failure (CHF);
- Negative urine pregnancy test for females ≥10 years of age (and of child bearing potential)
Who cannot join
- Peripheral blood smear positive for mixed infection with multiple Plasmodium spp.
- Severe or complicated malaria including subjects with any of the following:
- Impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria;
- Known hemoglobinuria;
- Jaundice;
- Respiratory distress;
Show all 16Show fewer
- Persistent vomiting;
- Gross hematuria, as reported by the subject's legally acceptable representative;
- Recent history of convulsions;
- Inability to drink or breastfeed;
- Unable to sit or stand as appropriate for age;
- Known pregnancy or breast-feeding or positive urine pregnancy test (females ≥10 years of age and of child bearing potential);
- History of allergy to or hypersensitivity to azithromycin, any macrolide, chloroquine, artemether, any artemisinin derivative, lumefantrine;
- Any contraindication to any study drug including AZ, CQ and AL;
- History of treatment with any antimalarial drug (such as halofantrine, chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment of a subject (and/or of the mother of a subject who is being breastfed) into the study;
- Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the investigator would place the subject at increased risk to participate in the study.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Burkina Faso2 sites
Pfizer Investigational Site
Nouna
Pfizer Investigational Site
Ouagadougou
Mali2 sites
Pfizer Investigational Site
Bamako, West Africa
Pfizer Investigational Site
Sikasso, West Africa
About this study
Official title: Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.
- Conditions
- Malaria, Falciparum
- Being tested
- Azithromycin plus Chloroquine, Artemether-lumefantrine
- Keywords
- P. Falciparum Malaria, drug treatment, clinical trial
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin plus ChloroquineDrug
Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
Artemether-lumefantrineDrug
Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Azithromycin plus Chloroquine |
| 2 | Experimental | Not described Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Day 28
Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population
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.
Measured: Day 28
Secondary outcomes (19)
Percentage of Participants With PCR-corrected ACPR in the mITT Population
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.
Measured: Days 7, 14, 21, 35, 42
Percentage of Participants With PCR-corrected ACPR in PP Population
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.
Measured: Days 7, 14, 21, 35, 42
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population
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.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With PCR-uncorrected ACPR in PP Population
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.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)
ETF defined as participants who met the following criteria:
- 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
- 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.
- Parasitemia (P. falciparum) on Day 3 with fever or
- 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.
Measured: Day 0 up to Day 3
Percentage of Participants With ETF in PP Population (PCR-corrected)
ETF defined as participants who met the following criteria:
- 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
- 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.
- Parasitemia (P.falciparum) on Day 3 with fever or
- 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.
Measured: Day 0 up to Day 3
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)
LCF included participants who met any of the following criteria:
- 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)
- 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.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With LCF in PP Population (PCR-corrected)
LCF included participants who met any of the following criteria:
- 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)
- 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.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)
LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With LPF in PP Population (PCR-corrected)
LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Measured: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)
Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Measured: Day 7, 14, 21, 28, 35, 42
Percentage of Participants With Gametocytologic Response
Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.
Measured: Days 7, 14, 21, 28, 35, 42
Fever Clearance Time
Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).
Measured: Baseline to Day 42
Asexual Plasmodium Falciparum Parasite Clearance Time
Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
Measured: Baseline to Day 42
Nadir Hemoglobin Level
Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.
Measured: Day 0 through Day 3
Change From Nadir Hemoglobin Level at Days 14, 28, and 42
Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.
Measured: Day 14, 28, 42
Time to Recurrence of Parasitemia
Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).
Measured: Baseline (Day 0) to Day 42
Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status
Measured: Baseline to Day 42
Percentage of Participants With PfCRT in True Failures
A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677833
- Sponsor's protocol ID
- A0661157
- Status last verified
- May 2014
- First submitted
- 12 May 2008
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8.
PubMed 25881046
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa
- ClinicalTrials.gov ID
- NCT00677833
- Acronym / sponsor ID
- A0661157
- Conditions
- Malaria, Falciparum
- Keywords
- P. Falciparum Malaria, drug treatment, clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin plus Chloroquine |
| 2 | Experimental | Drug: Artemether-lumefantrine |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Girls and boys ≥5 years to ≤12 years (Cohort 1); and ≥6 to ≤59 months of age (Cohort 2) with uncomplicated, symptomatic malaria as indicated by the presence of the following:
- Blood smears positive for monoinfection with P. falciparum and asexual parasitemia between 1000 -100,000 parasites/µL;
- Documented fever (38.0°C/100.4°F rectal or tympanic; 37.2°C/99.0°F axillary or 37.5°C/99.5°F oral) or history of fever (as reported by the legally acceptable representative) within the prior 24 hours;
- Appropriate for outpatient treatment;
- Blood glucose ≥60 mg/dL;
Key exclusion criteria (16 listed)
- Peripheral blood smear positive for mixed infection with multiple Plasmodium spp.
- Severe or complicated malaria including subjects with any of the following:
- Impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria;
- Known hemoglobinuria;
- Jaundice;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin plus ChloroquineCombination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) | Drug | 1 |
| Artemether-lumefantrineArtemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) | Drug | 2 |
Primary outcome
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
Time frame: 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.
Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population
Time frame: 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.
19 secondary outcomes
Percentage of Participants With PCR-corrected ACPR in the mITT Population
Time frame: Days 7, 14, 21, 35, 42
Percentage of Participants With PCR-corrected ACPR in PP Population
Time frame: Days 7, 14, 21, 35, 42
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With PCR-uncorrected ACPR in PP Population
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)
Time frame: Day 0 up to Day 3
Percentage of Participants With ETF in PP Population (PCR-corrected)
Time frame: Day 0 up to Day 3
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With LCF in PP Population (PCR-corrected)
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With LPF in PP Population (PCR-corrected)
Time frame: Days 7, 14, 21, 28, 35, 42
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)
Time frame: Day 7, 14, 21, 28, 35, 42
Percentage of Participants With Gametocytologic Response
Time frame: Days 7, 14, 21, 28, 35, 42
Fever Clearance Time
Time frame: Baseline to Day 42
Asexual Plasmodium Falciparum Parasite Clearance Time
Time frame: Baseline to Day 42
Nadir Hemoglobin Level
Time frame: Day 0 through Day 3
Change From Nadir Hemoglobin Level at Days 14, 28, and 42
Time frame: Day 14, 28, 42
Time to Recurrence of Parasitemia
Time frame: Baseline (Day 0) to Day 42
Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status
Time frame: Baseline to Day 42
Percentage of Participants With PfCRT in True Failures
Time frame: Baseline to Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25881046Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Azithromycin plus Chloroquine and Artemether-lumefantrine in people with Malaria, Falciparum, run by Pfizer at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Burkina Faso, Mali, Côte d’Ivoire, Ghana, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014; AzTrials last refreshed its copy on 26 Oct 2026.