Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00367653

Purpose

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

Condition	Intervention	Phase
Malaria	Drug: Azithromycin plus Chloroquine Drug: Mefloquine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Chloroquine diphosphate Chloroquine Mefloquine hydrochloride Mefloquine Azithromycin Chloroquine hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

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. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
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. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A secondary objective is to assess the efficacy of azithromycin plus chloroquine. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. [ Time Frame: duration of trial ] [ Designated as safety issue: Yes ]

Enrollment:	397
Study Start Date:	November 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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)
2: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367653

Locations

Burkina Faso
Pfizer Investigational Site
Nouna, Burkina Faso
Burkina Faso, West Africa
Pfizer Investigational Site
Ouagadougou, West Africa, Burkina Faso, 01
Ghana, West Africa
Pfizer Investigational Site
Navrongo, West Africa, Ghana
Kenya
Pfizer Investigational Site
kisumu, Kenya, 40100
Mali
Pfizer Investigational Site
Bamako, Mali
Mali, West Africa
Pfizer Investigational Site
Bamako, West Africa, Mali
Senegal, West Africa
Pfizer Investigational Site
Senegal, West Africa, Senegal
Zambia
Pfizer Investigational Site
Ndola, Zambia

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661155
Study First Received:	August 21, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00367653 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Malaria
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Sensory System Agents
Azithromycin
Therapeutic Uses
Parasitic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Amebicides
Mefloquine

Analgesics
Antinematodal Agents
Protozoan Infections
Coccidiosis
Filaricides
Chloroquine
Anthelmintics
Pharmacologic Actions
Malaria, Falciparum
Analgesics, Non-Narcotic
Chloroquine diphosphate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009