Condition category
Infections and Infestations
Date applied
30/11/2007
Date assigned
21/02/2008
Last edited
10/07/2013
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 Ambrose Talisuna

ORCID ID

Contact details

Epidemiology and Surveillance Division
Uganda Ministry of Health Headquarters
P.O. Box 7272
Kampala
-
Uganda
+256 (0)414 345 887
atalisuna@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2

Study information

Scientific title

Comparison of quinine, artemether lumefantrine and dihydroartemisinin piperaquine for retreatment of recurrent malaria in Ugandan children

Acronym

Study hypothesis

There is no difference in the efficacy and safety of quinine and two artemisinin-based combination therapies (ACTs) (artemether lumefantrine [AL] and dihydroartemisinin piperaquine [DP]) for treatment of recurrent uncomplicated malaria.

Ethics approval

Ethics approval received from:
1. Makerere University Faculty of Medicine Research and Ethics Committee on 5th October 2007
2. The Uganda National Council of Science and Technology on 9th November 2007 (ref: HS 362)

Study design

Nested phase IV, randomised, single blinded, multi-arm clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

The patients will be randomised to either quinine or another ACT regimen:
1. AL to quinine or DP
2. Chlorproguanil hydrochloride-dapsone-artesunate [CDA] to quinine
3. AL or DP
4. DP to quinine or AL

Patients are then followed for 28 days to assess their response to therapy.

Intervention type

Drug

Phase

Phase IV

Drug names

Artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DP), quinine, chlorproguanil hydrochloride-dapsone-artesunate (CDA)

Primary outcome measures

1. Polymerase chain reaction (PCR) unadjusted treatment failure up to day 28
2. PCR adjusted treatment failure up to day 28

Secondary outcome measures

1. Fever clearance time
2. Asexual parasite clearance time
3. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment
4. Haemoglobin (Hb) changes day 28 or day of treatment failure
5. Change in the frequency of plasmodial genetic polymorphisms (pfmdr1) as longitudinal markers of antimalarial drug resistance
6. Safety profiles including significant changes in relevant laboratory values

Overall trial start date

01/12/2007

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females aged between 1 and 5 years inclusive
2. Recurrent Plasmodium falciparum infection after treatment with ACTs in a related main study
3. Parents' or guardiansÂ’ 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

260

Participant exclusion criteria

1. Known hypersensitivity to the study drugs
2. Severe malaria
3. Danger signs:
3.1. Not able to drink or breast-feed
3.2. Vomiting (greater than twice in 24 hours)
3.3. Recent history of convulsions (greater than 1 in 24 hours)
3.4. Unconscious state
3.5. Unable to sit or stand
4. Early treatment failure in the main study

Recruitment start date

01/12/2007

Recruitment end date

01/12/2008

Locations

Countries of recruitment

Uganda

Trial participating centre

Epidemiology and Surveillance Division
Kampala
-
Uganda

Sponsor information

Organisation

Uganda Malaria Surveillance Project (Uganda)

Sponsor details

P.O. Box 7475
Kampala
-
Uganda
+256 (0)414 530 692
ctugaineyo@muucsf.org

Sponsor type

Research organisation

Website

http://www.muucsf.org

Funders

Funder type

Research organisation

Funder name

Department for International Development (DFID) (UK) - through Malaria Consortium (ref: SUBK026(2))

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23349741

Publication citations

  1. Results

    Yeka A, Tibenderana J, Achan J, D'Alessandro U, Talisuna AO, Efficacy of quinine, artemether-lumefantrine and dihydroartemisinin-piperaquine as rescue treatment for uncomplicated malaria in Ugandan children., PLoS ONE, 2013, 8, 1, e53772, doi: 10.1371/journal.pone.0053772.

Additional files

Editorial Notes