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Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Navrongo, , Ghana
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Written informed consent of the subject or a legally authorized representative

- Females and males

- >= 18 years of age with uncomplicated, symptomatic malaria as indicated by the
presence of both of the following: a.) Blood smears positive for Plasmodium
falciparum monoinfection, with asexual parasitemia between 1000 -100,000 parasites/mL
b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F
axillary or >= 38 C/100.4 F oral) within the prior 24 hours

- Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection)

- Rapid diagnostic test (Binax NOW ICT) positive for P. falciparum

- Subjects must be willing to be treated in the inpatient setting for a minimum of
three days

- Women of childbearing potential must have a negative urine gonadotropin prior to
entry into the study and must agree to use adequate contraception during the entire
study

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

- Severe or complicated malaria including subjects with any of the following: a.)
Impaired consciousness (e.g. obtundation, unarousable coma), seizures (any seizure
within 24 hours prior to enrollment) or abnormal neurologic exam suggestive of severe
or complicated malaria b.) Hemoglobinuria c.) Jaundice d.) Respiratory distress
(respiratory rate >= 30/min) e.) Persistent vomiting f.) Hematuria, as reported by
the patient

- Presence of non-falciparum species on microscopy

- Pregnant or breast-feeding women

- History of allergy to or hypersensitivity to azithromycin or any macrolide,
mefloquine or related compounds (e.g. quinine and quinidine), or chloroquine

- Known or suspected folate deficiency

- Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis,
aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)

- Known G-6PD deficiency

- History of epilepsy or psoriasis

- History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine,
Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial
activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment
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. The following findings are specific exclusions: a.) Serum creatinine >2.0 x
ULN b.) ALT and/or AST >3 x ULN

- Active depression or a recent history of depression, generalized anxiety disorder,
psychosis, schizophrenia or other major psychiatric disorders

- Inability to swallow oral medication in tablet form

- Treatment with other investigational drugs within 30 days prior to enrollment into
the study

- Alcohol and/or any other drug abuse

- Requirement to use medication during the study that might interfere with the
evaluation of the study drug

- Specific systemic diseases or other medical conditions that would interfere with the
evaluation of the therapeutic response or safety of the study drug

- Inability to comprehend and/or unwillingness to follow the study protocol

- Prior participation in this study

NCT00082576
Pfizer
Completed
Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

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Descriptive Information
Brief Title  ICMJE Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa
Official Title  ICMJE A Phase II/III, Randomized, Double-Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
Brief SummaryThe primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Malaria, Falciparum
Intervention  ICMJE
  • Drug: Azithromycin/Chloroquine
  • Drug: Mefloquine
Study Arms  ICMJE Not Provided
Publications *Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimdé AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.


*   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: May 10, 2011)
238
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent of the subject or a legally authorized representative
  • Females and males
  • >= 18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum monoinfection, with asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours
  • Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection)
  • Rapid diagnostic test (Binax NOW ICT) positive for P. falciparum
  • Subjects must be willing to be treated in the inpatient setting for a minimum of three days
  • Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study

Exclusion Criteria:

  • Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness (e.g. obtundation, unarousable coma), seizures (any seizure within 24 hours prior to enrollment) or abnormal neurologic exam suggestive of severe or complicated malaria b.) Hemoglobinuria c.) Jaundice d.) Respiratory distress (respiratory rate >= 30/min) e.) Persistent vomiting f.) Hematuria, as reported by the patient
  • Presence of non-falciparum species on microscopy
  • Pregnant or breast-feeding women
  • History of allergy to or hypersensitivity to azithromycin or any macrolide, mefloquine or related compounds (e.g. quinine and quinidine), or chloroquine
  • Known or suspected folate deficiency
  • Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)
  • Known G-6PD deficiency
  • History of epilepsy or psoriasis
  • History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment 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. The following findings are specific exclusions: a.) Serum creatinine >2.0 x ULN b.) ALT and/or AST >3 x ULN
  • Active depression or a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders
  • Inability to swallow oral medication in tablet form
  • Treatment with other investigational drugs within 30 days prior to enrollment into the study
  • Alcohol and/or any other drug abuse
  • Requirement to use medication during the study that might interfere with the evaluation of the study drug
  • Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug
  • Inability to comprehend and/or unwillingness to follow the study protocol
  • Prior participation in this study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ghana,   Mali,   Uganda,   Zambia
Removed Location CountriesBurkina Faso
 
Administrative Information
NCT Number  ICMJE NCT00082576
Other Study ID Numbers  ICMJE A0661134
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

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]

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