Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India

PLASMODIUM FALCIPARUM MALARIA Clinical Trial

Official title:

A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074841
• Other study ID #: A0661120
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 22, 2003
• Last updated: May 9, 2011
• Start date: September 2003
• Est. completion date: January 2005

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

This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• 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 asexual parasitemia between 1000 -100,000 parasites/uL; b.) Fever or history of fever ( >=38.5C/101.2F rectal or tympanic; >=37.5C/99.5F axillary or >=38C/100.4F oral) within the prior 24 hours

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

• Positive rapid diagnostic test (Binax NOW ICT) positive for P. falciparum

• 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 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

• Pregnant or breast-feeding women

• History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, 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

• 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: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• PLASMODIUM FALCIPARUM MALARIA

Intervention

Drug:
• Azithromycin/Chloroquine

• Sulfadoxine-Pyrimethamine/Chloroquine

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Bambolim	Gao
India	Pfizer Investigational Site	Dispur Guwahati	Assam
India	Pfizer Investigational Site	Indore
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Parel Mumbai	Maharashtra
India	Pfizer Investigational Site	Rourkela	Orissa
India	Pfizer Investigational Site	Vellore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India,