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| Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India |
| ISRCTN | ISRCTN84408319 |
| ClinicalTrials.gov identifier | |
| Public title | Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | DND-ASQ-06 |
| Study hypothesis |
1. To measure the clinical and parasitological efficacy of the fixed-dose artesunate/amodiaquine combination therapy among children and adults patients (6-month to 60-year old) suffering from uncomplicated falciparum malaria, by determining the proportion of patients achieving a negative parasitaemia without relapse before 28 days (cure rate)
2. To measure the parasite reduction ratio at 48 hours of treatment, parasite clearance time, fever clearance time, proportion of patients with gametocyte persistence at end-of-treatment 3. To evaluate the incidence of adverse events 4. To formulate recommendations and to enable the Ministry of Health to make informed decisions about the possible need for updating of the current national antimalarial treatment guidelines |
| Lay summary | |
| Ethics approval | Received from the Institutional Ethics Committee of the National Institute of Malaria Research (ICMR) on the 26th September 2006. |
| Study design | Multicentre, open-label randomised clinical trial |
| Countries of recruitment | India |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. Children and adults from 6 months to 60 years of age, both genders
2. For children: body weight greater than 5 kg 3. Uncomplicated falciparum malaria 4. Axillary temperature greater than 37.5°C 5. P. falciparum parasitaemia 1000 - 100,000 asexual forms/µL 6. Ability to swallow oral medication 7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 8. Written informed consent (participant or parent/guardian) |
| Participants - exclusion criteria |
1. Presence of general danger signs among the children less than 5 years old or other signs of severe and complicated falciparum malaria according to current World Health Organization (WHO) definitions
2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition 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 disease (e.g. cardiac, renal, hepatic diseases, human immunodeficiency virus [HIV]/acquired immune deficiency syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Positive pregnancy test or lactating 7. H/O antimalarial treatment in past 15 days |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 300 patients |
| Interventions |
Patients will be randomised into the following treatment groups (2:1):
Group A: fixed-dose AS/AQ combination tablets (paediatric: 25 mg/67.5 mg - adult: 100 mg/270 mg), oral route, dose according to age, once-daily during three days Group B: AQ tablets, oral route, dose according to age, three-day course |
| Primary outcome measure(s) | Cure rate: proportion of patients with 'Adequate Clinical and Parasitological Response' (ACPR) as defined by WHO. |
| Secondary outcome measure(s) |
Secondary efficacy endpoints:
1. Parasite reduction ratio (PRR) at 48 hours 2. Parasite clearance time 3. Fever clearance time 4. Proportion of patients with gametocytes persistence at end-of-treatment 5. Proportion of patients with early treatment failure (ETF), late treatment failure (LTF), and late parasitological failure (LPF) Safety variables: Incidence of any adverse event will be documented. All patients will be routinely asked about old symptoms and new symptoms emerging since previous visit. |
| Sources of funding |
1. Medecins Sans Frontieres (MSF) (International)
2. The Netherlands Ministry of Foreign Affairs (DGIS) (The Netherlands) 3. The Department For International Development (DFID) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Neena Valecha |
| Address | National Institute of Malaria Research |
| City/town | New Delhi |
| Zip/Postcode | 110029 |
| Country | India |
| Sponsor | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Address | 15 Chemin Louis Dunant |
| City/town | Geneva |
| Zip/Postcode | CH-1202 |
| Country | Switzerland |
| Sponsor website: | http://www.dndi.org/ |
| Date applied | 15/01/2008 |
| Last edited | 24/11/2008 |
| Date ISRCTN assigned | 30/01/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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