Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia
| ISRCTN | ISRCTN51688713 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51688713 |
| Secondary identifying numbers | 7070 |
- Submission date
- 03/10/2008
- Registration date
- 09/10/2008
- Last edited
- 28/03/2017
- 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 Richard Smith
Scientific
Scientific
Saclepea CHC
Nimba county
-
Liberia
Study information
| Study design | Randomised single-blind two-armed single-centre comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia |
| Study objectives | 1. To evaluate the efficacy of amodiaquine-artesunate and artemether-lumefantrine among children between 6 and 59 months old suffering from uncomplicated malaria defined as the polymerase chain reaction (PCR)-adjusted cure rates at day 42 2. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria 3. To assess inter-patient absorption differences possibly influencing efficacy 4. To formulate recommendations for adapted case management in Nimba county |
| Ethics approval(s) | 1. French CPP, 03/07/2008 2. Liberian Ministry of Health and Social Welfare, approval on 23/09/2008 |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Patients will be equally randomised into the following treatment groups: 1. Artesunate-amodiaquine fixed dose combination (AS/AQ FDC) (artesunate amodiaquine Winthrop® Sanofi Aventis): 1.1. Artesunate 25 mg/amodiaquine 67.5 mg 1 tablet/day for 3 days in children 5 kg to 8.9 kg 1.2. Artesunate 50 mg/amodiaquine 135 mg 1 tablet/day for 3 days in children 9 kg to 17.9 kg 1.3. Artesunate 100 mg/amodiaquine 270 mg 1 tablet/day for 3 days in children 18 kg to 35.9 kg 2. Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days: 2.1. One tablet/dose for weight 5 - 14.9 kg (total 6 tablets) 2.2. Two tablets/dose for weight 15 - 24.9 kg (total 12 tablets) 2.3. Three tablets/dose for weight 25 - 34.9 kg (total 18 tablets) 2.4. Four tablets/dose for weight greater than or equal to 35 kg (total 24 tablets) The second dose will be given 8 to 12 hours after the first dose, given at inclusion. Patients will be given milk, or encouraged to breastfeed, before each dose is taken. For both arms: 3 days of treatment + 39 follow-up days (study duration/patient = 42 days). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amodiaquine, artesunate, artemether, lumefantrine |
| Primary outcome measure | 1. To evaluate the efficacy of both drugs uncorrected by PCR genotyping at day 42 and to compare the re-infection rates 2. To evaluate the PCR corrected and uncorrected efficacy of amodiaquine-artesunate and artemether-lumefantrine on day 28 of follow up |
| Secondary outcome measures | 1. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria by documenting adverse events that occurred during the study, before: 1.1. Day 28 1.2. Day 42 1.3. By documenting serious adverse events (SAE) 2. To assess inter patient absorption differences possibly influencing efficacy by measuring the pharmacokinetic (PK) of amodiaquine and lumefantrine at day 0 and day 7 |
| Overall study start date | 17/11/2008 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Age group of 6 and 59 months, either sex 2. Weight greater than or equal to 5 kg 3. Slide-confirmed infection with Plasmodium falciparum only (no mixed infections) 4. Asexual parasite density between 2,000 and 200,000/µl of blood, and 5. Measured axillary temperature greater than or equal to 37.5°C or history of fever in the last 48 hours, and 6. High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.), and 7. Informed consent from a parent or guardian aged at least 18 years |
| Key exclusion criteria | 1. General danger signs according to the World Health Organization (WHO) definition 2. Signs of severe/complicated malaria according to the WHO definition 3. Severe anaemia (haemoglobin less than 5 g/dL) 4. Known history of hypersensitivity to any of the study drugs 5. Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet) 6. Concomitant febrile illness judged as due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc; mild flu shouldn't lead to exclusion) 7. Having received already a full course of the treatment (or one of the treatments) under study in the previous 10 days |
| Date of first enrolment | 17/11/2008 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Liberia
Study participating centre
Saclepea CHC
Nimba county
-
Liberia
-
Liberia
Sponsor information
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Research organisation
Research organisation
15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
| Website | http://www.dndi.org/ |
|---|---|
"ROR" |
https://ror.org/022mz6y25 |
Funders
Funder type
Research organisation
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
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 | results | 17/07/2013 | Yes | No | |
| Results article | results | 17/07/2013 | Yes | No | |
| Results article | results | 05/09/2016 | Yes | No |
Editorial Notes
28/03/2017: Publication reference added.
13/05/2010: This record was updated to include the actual last patient visit date; the overall trial end date at the time of registration was 30/04/2009.
