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Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nouna, , Burkina Faso
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Falciparum Malaria
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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;

- 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.

NCT00677833
Pfizer
Completed
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

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Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Azithromycin plus Chloroquine
    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)
  • Drug: Artemether-lumefantrine
    Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
  • Experimental: 1
    Intervention: Drug: Azithromycin plus Chloroquine
  • Experimental: 2
    Intervention: Drug: Artemether-lumefantrine
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
September 2010
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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;
  • 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.
Sexes Eligible for Study: All
6 Months to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Côte D'Ivoire,   Ghana,   Kenya,   Mali
Zambia
 
NCT00677833
A0661157
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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