Condition category
Infections and Infestations
Date applied
21/03/2005
Date assigned
05/05/2005
Last edited
25/08/2011
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 Umberto D'Alessandro

ORCID ID

Contact details

Prince Leopold Institut of Tropical Medicine
Nationalestraat 155
Antwerp
B-2000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ST3073+ST3074 DM040011

Study information

Scientific title

Acronym

Study hypothesis

The primary objective of the study is to measure the Day 28, PCR corrected cure rates of Artekin and Coartem and demonstrate that:
1. The cure rate of Artekin is non-inferior to that of Coartem (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 28.

Ethics approval

No ethics information 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

Dihydroartemisinin + Piperaquine (DHA + PPQ, Artekin ®) tablets containing 20 mg or 40 mg of Dihydroartemisinin and 160 mg or 320 mg of Piperaquine in comparison with Artemether + Lumefantrine (A + L, Coartem ®) tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.

Intervention type

Drug

Phase

Phase III

Drug names

Dihydroartemisinin, Piperaquine, Artemether and Lumefantrine

Primary outcome measures

The Day 28, Polymerase Chain Reaction (PCR) corrected cure rates of Artekin and Coartem.

Secondary outcome measures

1. Comparison of the uncorrected Day 28 cure rates of both drugs
2. Comparison of the safety profiles of the two treatments
3. Comparison of times of parasite clearance
4. Comparison of time of fever clearance
5. Comparison of gametocytes (prevalences and densities)
6. Comparison of haemoglobin (Hb) changes from day zero to day 28
7. Comparison of cure rates at D42 (PCR corrected and uncorrected)

Overall trial start date

01/05/2005

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and Females aged between six months and 59 months inclusive
2. Body weight at least 5 kg
3. Microscopically confirmed, monoinfection of Plasmodium falciparum
4. History of fever or presence of fever (axillary temperature at more than or equal to 37.5°C)
5. Written informed consent.
6. 1500 patients (1000 DHA + PPQ; 500 A + L)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1500

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/2005

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Burkina Faso, Kenya, Mozambique, Uganda, Zambia

Trial participating centre

Prince Leopold Institut of Tropical Medicine
Antwerp
B-2000
Belgium

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

http://home.sigma-tau.it/

Funders

Funder type

Charity

Funder name

Medicines for Malaria Venture (MMV)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19936217

Publication citations

  1. Results

    Bassat Q, Mulenga M, Tinto H, Piola P, Borrmann S, Menéndez C, Nambozi M, Valéa I, Nabasumba C, Sasi P, Bacchieri A, Corsi M, Ubben D, Talisuna A, D'Alessandro U, Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial., PLoS ONE, 2009, 4, 11, e7871, doi: 10.1371/journal.pone.0007871.

Additional files

Editorial Notes