Condition category
Infections and Infestations
Date applied
09/06/2008
Date assigned
24/07/2008
Last edited
10/05/2012
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 Steffen Borrmann

ORCID ID

Contact details

Im Neuenheimer Feld 350
Heidelberg
69120
Germany
+49 (0)6221 56 7756
steffen.borrmann@urz.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0.6

Study information

Scientific title

A randomised open label study to assess the safety and efficacy of dihydroartemisinin-piperaquine (Artekin™) compared with lumefantrine-artemether (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children

Acronym

Study hypothesis

Dihydroartemisinin-piperaquine is at least as efficacious as artemether-lumefantrine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum.

Ethics approval

Ethics approval received from:
1. Kenya Medical Research Institute, National Ethic Review Committee (Kenya) on the 26th June 2005
2. University of Oxford, Oxford Tropical Research Ethics Committee (UK) on the 6th July 2005
3. University of Heidelberg School of Medicine, Ethics Committee (Germany) on the 8th August 2005

Study design

Randomised, open label, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Uncomplicated Plasmodium falciparum malaria

Intervention

1. Three-day, three-dose regimen of dihydroartemisinin-piperaquine (Artekin™); co-formulation: target dose of 2 mg/kg/ once per day of dihydroartemisinin and target dose of 18 mg/kg/once per day of piperaquine
2. Three-day, six-dose regimen of artemether-lumefantrine (Coartem®); co-formulation containing 20 mg of artemether and 120 mg of lumefantrine:
2.1. 5 kg to less than 15 kg: one tablet/twice per day
2.2. 15 kg to less than 25 kg: two tablets/twice per day
2.3. 25 kg to less than 35 kg: three tablets/twice per day

Patients are followed-up for 84 days.

Intervention type

Drug

Phase

Not Specified

Drug names

Dihydroartemisinin-piperaquine (Artekin™), lumefantrine-artemether (Coartem®)

Primary outcome measures

1. The cure ratio of dihydroartemisinin-piperaquine is non-inferior to that of artemether-lumefantrine (non-inferiority margin = 5%)
2. The cure ratio of dihydroartemisinin-piperaquine is at least 90%

Secondary outcome measures

1. Polymerase chain reaction (PCR)-uncorrected day 28 cure ratio
2. Safety profiles of the two treatments
3. Time to asexual parasite clearance (PCT)
4. Time to fever clearance (FCT)
5. Gametocyte prevalence and density on days 7, 14, 28, 42, 63 and 84
6. Haematological recovery (Haemoglobin [Hb] changes) from day 0 to day 28, day 42, and day 84
7. Cure ratios at day 42 (PCR corrected and PCR uncorrected)
8. Cure ratios at day 63 (PCR corrected and PCR uncorrected)
9. Cure ratios at day 84 (PCR corrected and PCR uncorrected)
10. Rate of PCR-confirmed reinfections to estimate the chemoprophylactic effect of dihydroartemisinin-piperaquine

Overall trial start date

01/09/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females aged between 6 months and 59 months inclusive
2. Body weight of 5 kg and above
3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/μL to 200,000/μL)
4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C)
5. Signed informed consent by the parents or guardians
6. Parents’ or guardians’ willingness and ability to comply with the study protocol for the duration of the trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Participation in any investigational drug study during the previous 30 days
2. Known hypersensitivity to the study drugs
3. Severe malaria
4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand
5. Electrocardiogram (ECG) abnormality that requires urgent management
6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study
7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference)

Recruitment start date

01/09/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Kenya

Trial participating centre

Im Neuenheimer Feld 350
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg School of Medicine (Germany)

Sponsor details

Im Neuenheimer Feld 672
Heidelberg
69120
Germany
+49 (0)6221 56 4691
martina.weiss@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.uni-heidelberg.de/index_e.html

Funders

Funder type

Research organisation

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

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22102856

Publication citations

  1. Results

    Borrmann S, Sasi P, Mwai L, Bashraheil M, Abdallah A, Muriithi S, Frühauf H, Schaub B, Pfeil J, Peshu J, Hanpithakpong W, Rippert A, Juma E, Tsofa B, Mosobo M, Lowe B, Osier F, Fegan G, Lindegårdh N, Nzila A, Peshu N, Mackinnon M, Marsh K, Declining responsiveness of Plasmodium falciparum infections to artemisinin-based combination treatments on the Kenyan coast., PLoS ONE, 2011, 6, 11, e26005, doi: 10.1371/journal.pone.0026005.

Additional files

Editorial Notes