Condition category
Infections and Infestations
Date applied
24/03/2006
Date assigned
05/05/2006
Last edited
16/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ouedraogo Jean Bosco

ORCID ID

Contact details

399 Avenue de la Liberte
P O Box 545
Bobo-Dioulasso
01
Burkina Faso
+226 20981880
jbouedraogo.irss@fasonet.bf

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The efficacy of amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine for the treatment of uncomplicated falciparum malaria in Bobo-Dioulasso, Burkina Faso will be equivalent

Ethics approval

Approved by the Institutional Review Board (IRB) Centre Muraz, University of California San Francisco Committee for Human Research, reference number: H2397-2758-01 and by the IRB Institute for Resource and Security Studies (IRSS), reference number: 019-2005/CE-CM

Study design

Randomized, single-blinded, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

Subjects will be randomized to receive treatment with amodiaquine sulfadoxine pyrimethamine or artemether lumefantrine. Subjects in amodiaquine group will receive placebo to ensure the same number of doses in the two groups. Repeated therapy will be quinine.

Intervention type

Drug

Phase

Not Specified

Drug names

Amodiaquine sulfadoxine pyrimethamine and artemether lumefantrine

Primary outcome measures

The risk of clinical and parasitological treatment failure after 28 days of follow-up. Pairwise comparisons between regimens will be made on based on a per protocol analysis.

Secondary outcome measures

1. Risk of clinical failure after 14 days of follow-up
2. Risk of rescue therapy after 28 days of follow-up
3. Risk of fever during the first 3 days of follow-up: presence or absence of objective fever (axillary temperature >37.5 °C) or patient report of fever on days 1, 2, 3
4. Risk of parasitemia on follow-up days 2 and 3: proportion of positive versus negative thick blood smears on days 2 and 3
5. Change in mean hemoglobin from day 0 to 28 or day of repeat therapy
6. Proportion gametocytemic: presence versus absence of gametocytes on any follow-up thick blood smear; proportion gametocytemic on days 2, 3, 7, 14, 21, and 28
7. Risk of serious adverse events: proportion of patients experiencing any serious adverse event in each treatment group during the 28-day follow-up period, excluding treatment failures
8. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding treatment failures

Overall trial start date

02/08/2005

Overall trial end date

22/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age ≥6 months
2. Fever (≥37.5 or history of fever in the last 24 hours)
3. Provision of informed consent
4. P. falciparum mono infection
5. Parasite density >2000 microliters and ≥200,000 microliters

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

521

Participant exclusion criteria

1. Evidence of severe malaria
2. History of side effects to the investigational product
3. Pregnancy
4. Repeated vomiting of study medication on day 0
5. Hemoglobin <5 g/Dl
6. Evidence of concomitant febrile illness

Recruitment start date

02/08/2005

Recruitment end date

22/12/2005

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

399 Avenue de la Liberte
Bobo-Dioulasso
01
Burkina Faso

Sponsor information

Organisation

Institute of Research in Health Sciences (Institut de Recherches en Sciences de la Sante [IRSS]) (Burkina Faso)

Sponsor details

399 Avenue de la Liberte
P O Box 545
Bobo-Dioulasso
01
Burkina Faso
+226 20981880
jbouedraogo.irss@fasonet.bf

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Fogarty International Center (part of the National Institutes of Health (FIC-NIH), D43 TW01506-05 (subcontract TW/8420599)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Budget of Institut de Recherches en Sciences de la Sante (IRSS) and International Atomic Energy Agency (IAEA) RAF 6/025

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17292769

Publication citations

  1. Zongo I, Dorsey G, Rouamba N, Tinto H, Dokomajilar C, Guiguemde RT, Rosenthal PJ, Ouedraogo JB, Artemether-lumefantrine versus amodiaquine plus sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised non-inferiority trial., Lancet, 2007, 369, 9560, 491-498, doi: 10.1016/S0140-6736(07)60236-0.

Additional files

Editorial Notes