Condition category
Infections and Infestations
Date applied
14/08/2007
Date assigned
15/08/2007
Last edited
11/09/2007
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

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

http://www.who.int/malaria/

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

Publication citations

Additional files

Editorial Notes