Contact information
Type
Scientific
Primary contact
Dr Pascal Ringwald
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 34 69
ringwaldp@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC221
Study information
Scientific title
Acronym
Study hypothesis
To compare the efficacy and safety of artemether-lumefantrine and artesunate and amodiaquine in three sites in Togo.
Ethics approval
Ethics approval received from:
1. Ministere de la Sante du Togo on the 7th March 2007 (ref: 0109/2007/MS/CAB)
2. Ethics Review Committee of the World Health Organization (WHO) on the 11th June 2007 (ref: RPC221)
Study design
Randomised open two-arm controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
Patients will receive both of the following:
1. Artemether-lumefantrine: six doses over three days per os according to manufacturer recommendation
2. Artesunate 4 mg/kg/day for three days per os and amodiaquine 10 mg/kg/day for three days per os
Joint Sponsor:
The World Health Organisation Regional Office for Africa (WHO AFRO)
Cite du Djoue
P.O. Box 06
Brazzaville
Congo
http://www.afro.who.int/malaria/
Principal Investigator:
Dr Monique Dorkenoo-Agbeko
143, rue Malfakassa
Sito-Aeroport Lome
BP 7941 Lome
7829 Togo
Tel: + 228 (0)221 38 01 154
Email: monicadork@yahoo.fr
Intervention type
Drug
Phase
Not Specified
Drug names
Artemether-lumefantrine, artesunate, amodiaquine
Primary outcome measures
Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected at day 28.
Secondary outcome measures
Prevalence of adverse events.
Overall trial start date
01/07/2007
Overall trial end date
31/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 6 to 59 months old
2. Infection with Plasmodium falciparum
3. Parasitaemia, 2000 - 200 000 asexual forms per µl
4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C
5. Ability to swallow oral medication
6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
7. Informed consent from the patient or from a parent or guardian in case of children
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
450
Participant exclusion criteria
1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions
2. Mixed or mono-infection with another Plasmodium species
3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the National Center for Health Statistics (NCHS)/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] less than 110 mm)
4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrom [AIDS])
5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
Recruitment start date
01/07/2007
Recruitment end date
31/10/2007
Locations
Countries of recruitment
Togo
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Funder name
The World Health Organization Regional Office for Africa (WHO AFRO) (Togo)
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