A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia
| ISRCTN | ISRCTN40020296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40020296 |
| Secondary identifying numbers | 7071 |
- 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) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia |
| Study objectives | 1. To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated Plasmodium falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine 2. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatments 3. To assess efficacy of treatment at 28 days 4. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine 5. To promote awareness of drug safety issues and pharmacovigilance amongst health-care workers 6. To evaluate the ability of this method to detect serious adverse events and other safety information in the post-registration phase |
| Ethics approval(s) | 1. French CPP, approval on 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 (AS-AQ Winthrop®, Sanofi-Aventis): tablet strength AS/AQ 100/270 mg. Participants will be dosed according to body weight: 18 - 35.9 kg = 1 x 100/270 mg tablet once daily Greater than 36 kg = 2 x 100/270 mg tablets once daily 2. Artemether-lumefantrine (Coartem, Novartis): tablet strength A/L 20/120 mg. Participants will be dosed according to body weight: 15 - 24.9 kg = 2 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages 25 - 34.9 kg = 3 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages Greater than 35 kg = 4 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages For both arms: 3 days of treatment + 25 follow-up days (study duration/patient = 28 days). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]), artemether-lumefantrine |
| Primary outcome measure | To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated P. falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine. The clinical tolerability will be defined as the occurrence of most common adverse events. |
| Secondary outcome measures | 1. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatment 2. To assess efficacy of treatment at 28 days (polymerase chain reaction [PCR] genotyping corrected) 3. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine |
| Overall study start date | 29/09/2008 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 1000 patients |
| Key inclusion criteria | 1. Aged greater than or equal to 6 years, either sex 2. Weight greater than or equal to 18 kg 3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours 4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection 5. Willingness to attend for follow-up 6. Signed informed consent by patient or responsible caregiver |
| Key exclusion criteria | 1. Pregnancy (pregnancy test to be performed in women of childbearing age) 2. Severe malaria 3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks 4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine 5. Severe anaemia (less than 5 g/dl haemoglobin) 6. Concomitant febrile illness if additional medication is required other than antipyretics |
| Date of first enrolment | 29/09/2008 |
| Date of final enrolment | 01/04/2009 |
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 |
Editorial Notes
28/03/2017: internal review.
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 31/05/2009.
