Condition category
Infections and Infestations
Date applied
11/09/2007
Date assigned
05/02/2008
Last edited
13/05/2015
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

Prof Francois Nosten

ORCID ID

Contact details

Shoklo Malaria Research Unit (SMRU)
P.O. Box 46
68/30 Baan Tung Road
Tak Province
Mae Sot
63110
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessing the efficacy of Dihydroartemisinin-piperaquine in African patients suffering of uncomplicated falciparum malaria and to determine the pharmacokinetics profile of piperaquine in children 2 - 10 years old presenting falciparum malaria

Acronym

Study hypothesis

Preliminary results of pharmacokinetic (PK) studies indicate that the disposition of piperaquine is altered in children compared to adults.

Ethics approval

1. Institut de Recherche en Science de la Sante/Centre Muraz (IRSS/CM) (Burkina Faso) , 26/07/2007, ref: 005-2007/CE-CM
2. University of California, San Francisco (USCF) committee on Human Research, 27/07/2007, ref: # H40380-31179-01

Study design

1. Treatment efficacy: open-label trial
2. Population kinetic studies will use sparse capillary sampling

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

Patients are given dihydroartemisin piperaquine once daily for three days. Treatment is weight based and directly observed by the study nurse. The follow up duration is 42 days.

The study is a one arm study but there is a randomisation to determine the groups where the patient will be included for the PK purpose.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dihydroartemisinin-piperaquine

Primary outcome measures

1. Determination of the pharmacokinetic profile of piperaquine in children with uncomplicated falciparum malaria
2. Assess the efficacy of dihydroartemisinin piperaquine

Secondary outcome measures

1. Risk of recurrent malaria*
2. Risk of clinical and parasitological treatment failure*
3. Prevalence of fever (defined as both subjective fever in the previous 24 hours and measured axillary temperature greater than 37.5ºC) on follow-up days 1, 2, and 3
4. Prevalence of parasitaemia on follow-up days 2 and 3
5. Change in mean haemoglobin from day 0 to 42 (or day of rescue therapy for patients classified as late clinical failure [LCF] or late parasitological failure [LPF])
6. Prevalence of gametocytaemia on follow-up days 2, 3, 7, 14, 21 and 28
7. Change in the prevalence of molecular markers possibly associated with drug resistance on day 0 or the day of recurrent parasitaemia, including polymorphisms in Plasmodium falciparum chloroquine resistance transporter (Pfcrt) and Plasmodium falciparum multidrug-resistance (Pfmdr1) genes
8. In vitro sensitivity to antimalarial drugs

*Risks will be estimated using the Kaplan-Meier product limit formula based on a modified intention-to-treat analysis.

Overall trial start date

06/08/2007

Overall trial end date

31/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

On day 0, patients with symptoms suggestive of malaria and a positive screening thick blood smear will be assessed for the following selection criteria by study physicians for appropriate care:
1. Not previously enrolled in this study
2. Aged greater than 6 months
3. Weight greater than 5 kg
4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. Provision of informed consent and ability to participate in 42-day follow-up (patient has easy access to health unit)
8. No history of antimalarial use in the previous two weeks (except for chloroquine)
9. No danger signs or evidence of severe malaria defined as:
9.1. Unarousable coma (if after convulsion, greater than 30 minutes)
9.2. Recent febrile convulsions (within 24 hours)
9.3. Altered consciousness (confusion, delirium, psychosis, coma)
9.4. Lethargy
9.5. Unable to drink or breast feed
9.6. Vomiting everything
9.7. Unable to stand/sit due to weakness
9.8. Severe anaemia (haemoglobin [Hb] less than 5.0 gm/dL)
9.9. Respiratory distress (laboured breathing at rest)
9.10. Jaundice

After going to the laboratory, the subjects will be referred to the study nurse for treatment allocation and treatment with the study medications. Patients must also meet the following criterion:
10. Absence of repeated vomiting of study medications on day 0

Patients will return to the clinic on day 1 and will be excluded from the study if the following inclusion criteria are not met:
11. Plasmodium falciparum mono-infection
12. Parasite density 2000 - 200,000/ul

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. Inhability to participate in 42 days follow up
2. Pregnant women
3. Severe malaria

Recruitment start date

06/08/2007

Recruitment end date

31/01/2008

Locations

Countries of recruitment

Burkina Faso, Thailand

Trial participating centre

Shoklo Malaria Research Unit (SMRU)
Mae Sot
63110
Thailand

Sponsor information

Organisation

Beijing Holley-Cotec Pharmaceuticals Co. Ltd (China)

Sponsor details

Room 1602
Full Tower
No. 9
Dong San Huan Zhong Road
Chaoyang District
Beijing
100020
China

Sponsor type

Industry

Website

http://www.holleycotec.com

Funders

Funder type

Charity

Funder name

Doris Duke Charitable Foundation (USA)

Alternative name(s)

DDCF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Beijing Holley-Cotec Pharmaceuticals Co. Ltd (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Budget of Institut de Recherche en Science de la Sante (IRSS) (Burkina Faso)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25133389

Publication citations

Additional files

Editorial Notes