NCT00282919

Brief Summary

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
2 countries

2 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

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

June 26, 2014

Completed
Last Updated

June 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.9 years

First QC Date

January 26, 2006

Results QC Date

May 27, 2014

Last Update Submit

May 27, 2014

Conditions

Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Parasite Clearance at Day 28

    Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.

    Day 28

Secondary Outcomes (8)

  • Percentage of Participants With Early Treatment Failures (ETF)

    Baseline up to Day 28

  • Percentage of Participants With Late Treatment Failures (LTF)

    Baseline up to Day 28

  • Percentage of Participants With Resistance to Treatment

    Days 7, 14, 21, 28, 35, 42

  • Percentage of Participants With Clinical Cure

    Day 3, 7, 28, and 42

  • Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42

    Day 7, 14, 21, 35, 42

  • +3 more secondary outcomes

Study Arms (1)

Azithromycin plus chloroquine

EXPERIMENTAL

Single Arm, Open label study

Drug: Azithromycin plus chloroquine

Interventions

Azithromycin plus chloroquineDRUG

dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Azithromycin plus chloroquine

Eligibility Criteria

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

You may qualify if:

  • Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

You may not qualify if:

  • Subjects with severe or complicated malaria. Pregnant or breast feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Tumaco, Departamento de Nariño, Colombia

Location

Pfizer Investigational Site

Bambolim, Goa, 403002, India

Location

Related Links

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

AzithromycinChloroquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

March 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

June 26, 2014

Results First Posted

June 26, 2014

Record last verified: 2014-05

Locations

IN(1)CO(1)