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
DOI	https://doi.org/10.1186/ISRCTN84408319
Secondary identifying numbers	DND-ASQ-06

Submission date: 15/01/2008
Registration date: 30/01/2008
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 Neena Valecha
Scientific

National Institute of Malaria Research
New Delhi
110029
India

Study information

Study design	Multicentre open-label randomised clinical trial
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	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
Study objectives	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
Ethics approval(s)	Institutional Ethics Committee of the National Institute of Malaria Research (ICMR), 26/09/2006
Health condition(s) or problem(s) studied	Malaria
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artesunate, amodiaquine
Primary outcome measure	Cure rate: proportion of patients with 'Adequate Clinical and Parasitological Response' (ACPR) as defined by WHO
Secondary outcome measures	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
Overall study start date	01/02/2007
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	300 patients
Key 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)
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

India

Study participating centre

National Institute of Malaria Research

New Delhi
110029
India

Sponsor information

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
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

Medecins Sans Frontieres (MSF) (International)

No information available

Ministerie van Buitenlandse Zaken
Government organisation / National government

Alternative name(s): Dutch Ministry of Foreign Affairs, Ministry of Foreign Affairs, Ministry of Foreign Affairs of the Kingdom of the Netherlands
Location: Netherlands

Department for International Development
Government organisation / National government

Alternative name(s): Department for International Development, UK, DFID
Location: United Kingdom

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	30/03/2012		Yes	No

Editorial Notes

28/03/2017: internal review.