Condition category
Infections and Infestations
Date applied
05/07/2007
Date assigned
21/08/2007
Last edited
24/11/2008
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 Bernhards Ogutu

ORCID ID

Contact details

Walter Reed Project
Centre for Clinical Research
KEMRI
P.O. Box 54
Kisumu
-
Kenya

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1199

Study information

Scientific title

Acronym

Study hypothesis

1. To investigate pharmacokinetic parameters of the fixed-dose artesunate/amodiaquine (AS/AQ) combination in adults with comparison to separate administration of the two drugs using a population pharmacokinetic design
2. To measure the clinical and parasitological efficacy of the fixed-dose AS/AQ combination therapy
3. To measure the parasite reduction ratio at 48 hours of treatment, parasite and fever clearance rates, proportions of patients with gametocyte persistence during follow up
4. To evaluate the incidence of adverse events
5. To formulate recommendations and to enable the Kenyan 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 ethics committee of the Kenya Medical Research Institute on the 22nd May 2007.

Study design

Open-label randomised, single centre clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Uncomplicated falciparum malaria

Intervention

Patients will be equally randomised into the following treatment groups:

Group A: fixed-dose AS/AQ combination tablets (100 mg/270 mg), two tablets once daily for three consecutive days.
Group B: AS tablets (50 mg): four tablets once a day for three consecutive days, and AQ tablets (153 mg): four tablets once a day for three consecutive days.

Patients will be followed-up for 28 days, and the total follow-up for the study will be 9 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Artesunate, amodiaquine

Primary outcome measures

The primary objective of this study is to investigate the pharmacokinetic properties of fixed-dose combination AS/AQ. Blood sampling will be performed at predefined time points in both groups of patients. The evaluation of pharmacokinetics variables will take place over the three-day treatment and the entire follow-up off-treatment.

Secondary outcome measures

1. Treatment outcomes: the classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest (2005) guidelines of World Health Organisation (WHO). Accordingly, all patients will be classified as having an Early Treatment Failure, a Late Clinical Failure, a Late Parasitological Failure, or an Adequate Clinical and Parasitological Response
2. Safety variables: the occurrence of any adverse event will be documented. All patients will be routinely asked about old symptoms and new symptoms emerging since previous visit during follow-up

Overall trial start date

09/07/2007

Overall trial end date

30/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults from 18 to 60 years of age; either gender
2. Presenting with acute uncomplicated falciparum malaria:
2.1. Oral temperature greater than 37.5°C, or
2.2. History of fever in the last 24 hours
3. Positive P. falciparum parasitaemia (greater than 1000 asexual parasites/µL)
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Any other concomitant febrile illness, e.g. upper respiratory tract infection or Ear, Nose and Throat (ENT) infection
2. Features of severe malaria
3. Mixed Plasmodium infection

Recruitment start date

09/07/2007

Recruitment end date

30/03/2008

Locations

Countries of recruitment

Kenya

Trial participating centre

Walter Reed Project
Kisumu
-
Kenya

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

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

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

Medecins Sans Frontieres (MSF) (International)

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

Publication citations

Additional files

Editorial Notes