Condition category
Infections and Infestations
Date applied
21/03/2005
Date assigned
05/05/2005
Last edited
25/07/2012
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

Prof Nicholas J White

ORCID ID

Contact details

Wellcome Trust Southeast Asian Tropical Medicine Research Units
Faculty of Tropical Medicine
Mahidol University
420/6 Rajvithi Road
Phayathai
Bangkok
10400
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ST3073+ST3074 DM040010

Study information

Scientific title

Acronym

Study hypothesis

The primary objective of the study is to measure the Day 63, polymerase chain reaction (PCR) corrected cure rates of artekin and AS + MQ and demonstrate that:
1. The cure rate of Artekin is non-inferior to that of AS + MQ (non-inferiority margin = 5%)
2. The cure rate of Artekin is at least 90%

This cure rate is defined as the proportion of patients with adequate clinical and parasitological response at Day 63 plus those treatment failures identified as new infection by PCR.

Ethics approval

Not provided at time of registration

Study design

Phase III, randomised, non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Malaria

Intervention

Randomisation will stratify infants, children and adults by age. Patients randomised to:
1. Tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine for adult patients or containing 20 mg of dihydroartemisinin and 160 mg of piperaquine for infants and children
2. Tablets containing 50 mg of artesunate and tablets containing 250 mg of mefloquine

Intervention type

Drug

Phase

Phase III

Drug names

Dihydroartemisinin + Piperaquine (DHA + PPQ, Artekin®) in comparison with Artesunate + Mefloquine (AS + MQ)

Primary outcome measures

The Day 63, PCR corrected cure rates of artekin and AS+MQ

Secondary outcome measures

1. The comparison of the uncorrected Day 63 cure rates of both drugs (also known as adequate clinical and parasitological response [ACPR])
2. The comparison of the amount of overall treatment failure
3. The comparison of the safety profiles of the two treatments
4. Proportion of patients with treatment failure (TF)
5. Proportion of aparasitaemic patients
6. Proportion of afebrile patients
7. Gametocytes carriage
8. Fractional change in haemoglobin/haematocrit

Overall trial start date

01/01/2000

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females aged between three months and 65 years inclusive
2. Body weight at least 5 kg
3. Microscopically confirmed, monoinfection of Plasmodium falciparum or mixed infection
4. History of fever or presence of fever (tympanic temperature at more than or equal to 37.5°C)
5. Written informed consent
6. 1050 patients (700 DHA + PPQ; 350 AS + MQ)

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

1050

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

01/01/2001

Locations

Countries of recruitment

India, Laos, Thailand

Trial participating centre

Wellcome Trust Southeast Asian Tropical Medicine Research Units
Bangkok
10400
Thailand

Sponsor information

Organisation

Sigma-Tau (Italy)

Sponsor details

Industrie Farmaceutiche Riunite
SpA
via Pontina Km. 30,400
Pomezia (Rome)
00040
Italy

Sponsor type

Industry

Website

Funders

Funder type

Charity

Funder name

Medicines for Malaria Venture (MMV) (Switzerland)

Alternative name(s)

MMV

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Switzerland

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20689583
2. 2012 results from India in http://www.ncbi.nlm.nih.gov/pubmed/22818552

Publication citations

  1. Results

    Valecha N, Phyo AP, Mayxay M, Newton PN, Krudsood S, Keomany S, Khanthavong M, Pongvongsa T, Ruangveerayuth R, Uthaisil C, Ubben D, Duparc S, Bacchieri A, Corsi M, Rao BH, Bhattacharya PC, Dubhashi N, Ghosh SK, Dev V, Kumar A, Pukrittayakamee S, Pukittayakamee S, An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia., PLoS ONE, 2010, 5, 7, e11880, doi: 10.1371/journal.pone.0011880.

  2. Results from India

    Gargano N, Ubben D, Tommasini S, Bacchieri A, Corsi M, Bhattacharyya PC, Rao BH, Dubashi N, Dev V, Ghosh SK, Kumar A, Srivastava B, Valecha N, Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated Plasmodium falciparum malaria in India., Malar. J., 2012, 11, 233, doi: 10.1186/1475-2875-11-233.

Additional files

Editorial Notes