ClinicalTrials.gg
Sign In
CompletedNCT01213433ASAQ-MALUpdated Jul 31, 2015

Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

A Phase 4 interventional study of Artesunate-Amodiaquine in Uncomplicated Malaria, sponsored by Centre Muraz. Completed at 1 site in Burkina Faso. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Centre Muraz · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Months and older
Sex
All
01

Study summary

This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.

02

Conditions studied

  • Uncomplicated Malaria
03

In context

Lead sponsor

Centre Muraz is the lead sponsor of 7 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Males and Females aged 6 months and above.
  • Body weight of 5 Kg and above.
  • RDT positive test.
  • Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
  • Signed (or thumb-printed whenever patients are illiterate) informed consent.
  • Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
  • Known hypersensitivity to the study drugs.
  • Severe malaria.
  • Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand.
  • Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
  • Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Amodiaquine+Artesunate

    Drug: Artesunate-Amodiaquine

Interventions

  • DrugArtesunate-Amodiaquine

    Drug pages: Artesunate · Amodiaquine

    Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

06

What researchers measure

Primary outcomes

  1. Treatment failure at day 28

    Time frame: 28 days

07

Study locations

1 site
  • CRUN
    Nanoro, Boulkiemdé 01, Burkina Faso
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01213433
Lead sponsor
Centre Muraz
Collaborators
Institute of Tropical Medicine, Belgium
Responsible party
Tinto Halidou (PharmD, PhD, Centre Muraz) — Principal investigator
First posted
Oct 4, 2010
Start date
Oct 2010
Primary completion
Nov 2010
Completion
Apr 2011
Last update
Jul 31, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. 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: Artesunate · Amodiaquine

Other studies from this sponsor

Centre Muraz

Start the discussion