A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

Pfizer

Status and phase: Completed; Phase 2

Conditions: Falciparum Malaria

Treatments: Drug: Azithromycin plus chloroquine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282919

A0661154

Details and patient eligibility

About

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

Exclusion criteria

• Subjects with severe or complicated malaria. Pregnant or breast feeding women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Azithromycin plus chloroquine

Experimental group

Description:

Single Arm, Open label study

Treatment:

Drug: Azithromycin plus chloroquine