Condition category
Infections and Infestations
Date applied
15/01/2008
Date assigned
30/01/2008
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neena Valecha

ORCID ID

Contact details

National Institute of Malaria Research
New Delhi
110029
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DND-ASQ-06

Study information

Scientific title

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Artesunate, amodiaquine

Primary outcome measures

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 trial start date

01/02/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

300 patients

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

India

Trial participating centre

National Institute of Malaria Research
New Delhi
110029
India

Sponsor information

Organisation

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Sponsor details

15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland

Sponsor type

Research organisation

Website

http://www.dndi.org/

Funders

Funder type

Research organisation

Funder name

Medecins Sans Frontieres (MSF) (International)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Ministry of Foreign Affairs (DGIS) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Department For International Development (DFID) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22458860

Publication citations

  1. Results

    Anvikar AR, Sharma B, Shahi BH, Tyagi PK, Bose TK, Sharma SK, Srivastava P, Srivastava B, Kiechel JR, Dash AP, Valecha N, Artesunate-amodiaquine fixed dose combination for the treatment of Plasmodium falciparum malaria in India., Malar. J., 2012, 11, 97, doi: 10.1186/1475-2875-11-97.

Additional files

Editorial Notes