NCT00367653

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

10 months

First QC Date

August 21, 2006

Last Update Submit

September 15, 2008

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: Azithromycin plus Chloroquine

2

EXPERIMENTAL
Drug: Mefloquine

Interventions

Azithromycin plus ChloroquineDRUG

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)

Also known as: Zithromax
1
MefloquineDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Ouagadougou, West Africa, 01, Burkina Faso

Location

Pfizer Investigational Site

Nouna, Burkina Faso

Location

Pfizer Investigational Site

Navrongo, West Africa, Ghana

Location

Pfizer Investigational Site

Kisumu, Kisumu County, 40100, Kenya

Location

Pfizer Investigational Site

Bamako, West Africa, Mali

Location

Pfizer Investigational Site

Bamako, Mali

Location

Pfizer Investigational Site

Senegal, West Africa, Senegal

Location

Pfizer Investigational Site

Ndola, Zambia

Location

Related Publications (1)

  • Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.

    PMID: 25425434DERIVED

Related Links

MeSH Terms

Conditions

Malaria

Interventions

AzithromycinChloroquineMefloquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2006

First Posted

August 23, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

GH(1)SE(1)BU(2)MA(2)KE(1)ZA(1)