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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria, Falciparum

Intervention: Azithromycin/Chloroquine (Drug); Mefloquine (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Parasite clearance

Secondary outcome: tolerability


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Pfizer Investigational Site, Navrongo, Ghana

Pfizer Investigational Site, Bamako, Mali

Pfizer Investigational Site, Jinja, Uganda

Pfizer Investigational Site, Kampala, Uganda

Pfizer Investigational Site, Ndola, Zambia

Pfizer Investigational Site, Unknown, Nairobi, Kenya

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2004
Last updated: May 10, 2011

Page last updated: August 23, 2015

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