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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367653
• Other study ID #: A0661155
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2006
• Last updated: September 15, 2008
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

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)
• 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

Locations

Country	Name	City	State
Burkina Faso	Pfizer Investigational Site	Nouna
Burkina Faso	Pfizer Investigational Site	Ouagadougou	West Africa
Ghana	Pfizer Investigational Site	Navrongo	West Africa
Kenya	Pfizer Investigational Site	Kisumu
Mali	Pfizer Investigational Site	Bamako	West Africa
Mali	Pfizer Investigational Site	Bamako
Senegal	Pfizer Investigational Site	Senegal	West Africa
Zambia	Pfizer Investigational Site	Ndola

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Burkina Faso,  Ghana,  Kenya,  Mali,  Senegal,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	A secondary objective is to assess the efficacy of azithromycin plus chloroquine.		duration of trial	No
Secondary	Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.		duration of trial	Yes

External Links

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