Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00367653

Collaborator

(none)

397

Enrollment

Locations

Arms

Duration (Months)

49.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Azithromycin plus Chloroquine Drug: Mefloquine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

397 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Azithromycin plus Chloroquine Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2) Other Names: Zithromax
Experimental: 2	Drug: Mefloquine Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0

Arm

Intervention/Treatment

Experimental: 1

Drug: Azithromycin plus Chloroquine

Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)

Other Names:

Zithromax

Experimental: 2

Drug: Mefloquine

Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0

Outcome Measures

Primary Outcome Measures

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. [duration of trial]
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population. [duration of trial]

Secondary Outcome Measures

A secondary objective is to assess the efficacy of azithromycin plus chloroquine. [duration of trial]
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. [duration of trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.

Exclusion Criteria:

Severe or complicated malaria.
Pregnant or breast-feeding women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ouagadougou	West Africa	Burkina Faso	01
2	Pfizer Investigational Site	Nouna		Burkina Faso
3	Pfizer Investigational Site	Navrongo	West Africa	Ghana
4	Pfizer Investigational Site	Kisumu		Kenya	40100
5	Pfizer Investigational Site	Bamako	West Africa	Mali
6	Pfizer Investigational Site	Bamako		Mali
7	Pfizer Investigational Site	Senegal	West Africa	Senegal
8	Pfizer Investigational Site	Ndola		Zambia