Monitoring the efficacy and safety of artemether-lumefantrine and artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Niamtougou, Sokode (Region Centrale) and Lome (Lome Commune) sentinels sites in Togo in 2007

ISRCTN	ISRCTN89012092
DOI	https://doi.org/10.1186/ISRCTN89012092
Secondary identifying numbers	RPC221

Submission date: 14/08/2007
Registration date: 15/08/2007
Last edited: 29/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pascal Ringwald
Scientific

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 34 69
Email	ringwaldp@who.int

Study information

Study design	Randomised open two-arm controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Monitoring the efficacy and safety of artemether-lumefantrine and artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Niamtougou, Sokode (Region Centrale) and Lome (Lome Commune) sentinels sites in Togo in 2007
Study objectives	To compare the efficacy and safety of artemether-lumefantrine and artesunate and amodiaquine in three sites in Togo.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artemether-lumefantrine, artesunate, amodiaquine
Primary outcome measure	Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected at day 28.
Secondary outcome measures	Prevalence of adverse events.
Overall study start date	01/07/2007
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	Both
Target number of participants	450
Total final enrolment	505
Key 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
Key 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
Date of first enrolment	01/07/2007
Date of final enrolment	31/10/2007

Locations

Countries of recruitment

Switzerland
Togo

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/malaria/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations

Alternative name(s): منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location: Switzerland

The World Health Organization Regional Office for Africa (WHO AFRO) (Togo)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	2005-2009 results	08/10/2012	29/09/2021	Yes	No

Editorial Notes

29/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.