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

Malaria, Falciparum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082576
• Other study ID #: A0661134
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 12, 2004
• Last updated: May 10, 2011
• Start date: June 2004
• Est. completion date: May 2006

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Azithromycin/Chloroquine

• Mefloquine

Locations

Country	Name	City	State
Ghana	Pfizer Investigational Site	Navrongo
Kenya	Pfizer Investigational Site	Unknown	Nairobi
Mali	Pfizer Investigational Site	Bamako
Uganda	Pfizer Investigational Site	Jinja
Uganda	Pfizer Investigational Site	Kampala
Zambia	Pfizer Investigational Site	Ndola

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Ghana,  Kenya,  Mali,  Uganda,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasite clearance
Secondary	tolerability

External Links

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