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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Azithromycin plus Chloroquine

Mefloquine

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1

2

Arm Description

Outcomes

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.

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.

Secondary Outcome Measures

A secondary objective is to assess the efficacy of azithromycin plus chloroquine.

Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.

Full Information

NCT ID

NCT00367653

First Posted

August 21, 2006

Last Updated

September 15, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00367653

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

397 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Azithromycin plus Chloroquine

Other Intervention Name(s)

Zithromax

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Mefloquine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

A secondary objective is to assess the efficacy of azithromycin plus chloroquine.

Time Frame

duration of trial

Title

Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.

Time Frame

duration of trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Ouagadougou

State/Province

West Africa

ZIP/Postal Code

01

Country

Burkina Faso

Facility Name

Pfizer Investigational Site

City

Nouna

Country

Burkina Faso

Facility Name

Pfizer Investigational Site

City

Navrongo

State/Province

West Africa

Country

Ghana

Facility Name

Pfizer Investigational Site

City

Kisumu

ZIP/Postal Code

40100

Country

Kenya

Facility Name

Pfizer Investigational Site

City

Bamako

State/Province

West Africa

Country

Mali

Facility Name

Pfizer Investigational Site

City

Bamako

Country

Mali

Facility Name

Pfizer Investigational Site

City

Senegal

State/Province

West Africa

Country

Senegal

Facility Name

Pfizer Investigational Site

City

Ndola

Country

Zambia

12. IPD Sharing Statement

Citations:

PubMed Identifier

25425434

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661155&StudyName=Azithromycin%20Plus%20Chloroquine%20Versus%20Mefloquine%20In%20the%20Treatment%20of%20%20Uncomplicated%20P.%20falciparum%20Malaria.

Description

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Malaria

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial