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

• Register: ISRCTN
• Last refreshed on: 11 October 2021
• Main ID: ISRCTN89012092
• Date of registration: 15/08/2007
• Prospective Registration: No
• Primary sponsor: World Health Organization (WHO) (Switzerland)
• Public 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
• 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
• Date of first enrolment: 01/07/2007
• Target sample size: 450
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN89012092
• Study type: Interventional
• Study design: Randomised open two-arm controlled study (Treatment)
• Phase: Not Specified

Countries of recruitment

Switzerland, Togo

Contacts

• Name: Pascal Ringwald

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Malaria

Intervention(s)

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: [e-mail]

Primary Outcome(s)

Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected at day 28.

Secondary Outcome(s)

Prevalence of adverse events.

Secondary ID(s)

RPC221

Source(s) of Monetary Support

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

Ethics review

Status:
Approval date:
Contact:

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)

Results

• Results available: Yes
• Date Completed: 31/10/2007