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

Not Applicable

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN89012092
• Lead Sponsor: World Health Organization (WHO) (Switzerland)

Brief Summary

2012 Results article in https://pubmed.ncbi.nlm.nih.gov/23043495/ 2005-2009 results (added 29/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-15
• Study Completion: 2007-10-31
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 505

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prevalence of adverse events.