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 |
| Protocol serial number | RPC221 |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funders | World Health Organization (WHO) (Switzerland), The World Health Organization Regional Office for Africa (WHO AFRO) (Togo) |
- 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
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 34 69 |
|---|---|
| ringwaldp@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open two-arm controlled study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artemether-lumefantrine, artesunate, amodiaquine |
| Primary outcome measure(s) |
Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected at day 28. |
| Key secondary outcome measure(s) |
Prevalence of adverse events. |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | All |
| Target sample size at registration | 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
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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.
