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

Last updated on December 17, 2017

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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Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa
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
The 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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Azithromycin/Chloroquine
  • Drug: Mefloquine
Not Provided
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.
 
Completed
238
May 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Ghana,   Mali,   Uganda,   Zambia
Burkina Faso
 
NCT00082576
A0661134
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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