ClinicalTrials.gg
Status unknownNCT00406146Updated Dec 4, 2006

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

A Phase 3 interventional study of amodiaquine+artesunate/artemether-lumefantrine in Uncomplicated Malaria, sponsored by University of Ghana Medical School. Status unknown at 1 site in Ghana. Open to participants aged 6 Months to 14 Years. Per ClinicalTrials.gov, last updated 2006-12-04.

Sponsored by University of Ghana Medical School · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
6 Months to 14 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Uncomplicated Malaria

Browse trials for

03

In context

Malaria

1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.

Browse Malaria studies →

Lead sponsor

University of Ghana Medical School is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 14 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by accompanying parent or guardian

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single

Interventions

06

Study locations

1 site
  • Korle Bu Teaching Hospital
    Accra, Ghana
07

References and documents

Publications

  • 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. PubMed 18620577 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00406146
Lead sponsor
University of Ghana Medical School
First posted
Dec 4, 2006
Start date
Oct 2004
Completion
Dec 2006
Last update
Dec 4, 2006

Study contacts

George O. Adjei, MD
principal investigator · Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Bamenla Q. Goka, MBchB
principal investigator · Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Jorgen A.L. Kurtzhals, MD, Ph.D
principal investigator · Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Amodiaquine · Artesunate

Start the discussion