MedDataX Logo

Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

NCT ID: NCT00406146

Last Updated: 2006-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uncomplicated Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

amodiaquine+artesunate/artemether-lumefantrine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* microscopically confirmed acute uncomplicated falciparum malaria;
* temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
* willingness to comply with follow up schedule;
* written informed consent by accompanying parent or guardian

Exclusion Criteria

* features of severe malaria or danger signs of malaria
* known intolerance or allergy to any of the study medications
* known treatment with any of the study medications in the month preceding enrollment
* serious underlying disease that may mask outcome assessment
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Ghana Medical School

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

George O. Adjei, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana

Bamenla Q. Goka, MBchB

Role: PRINCIPAL_INVESTIGATOR

Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana

Jorgen A.L. Kurtzhals, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Korle Bu Teaching Hospital

Accra, , Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

References

Explore related publications, articles, or registry entries linked to this study.

Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127. doi: 10.1186/1475-2875-7-127.

Reference Type DERIVED
PMID: 18620577 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GHN-202-M03-M-00

Identifier Type: -

Identifier Source: secondary_id

91199 / 104. DAN.8-864

Identifier Type: -

Identifier Source: org_study_id