You are here

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

Last updated on November 17, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria, Falciparum
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Azithromycin plus Chloroquine
  • Experimental: 2
    Intervention: Drug: Artemether-lumefantrine
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2011)
361
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)
424
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateSeptember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso,   Côte D'Ivoire,   Ghana,   Kenya,   Mali
Removed Location CountriesZambia
 
Administrative Information
NCT Number  ICMJE NCT00677833
Other Study ID Numbers  ICMJE A0661157
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now