Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria
QuinAct
A Randomized Clinical Trial to Measure the Impact of Retreatment With an Artemisinin-based Combination on Malaria Incidence and Its Potential Selection of Resistant Strains
1 other identifier
interventional
2,117
2 countries
2
Brief Summary
This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in RDCongo, on malaria incidence and its potential selection of resistant strains. Patients will be followed-up for efficacy and safety during 42 days after treatment with the first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or an other ACT or oral Quinine + clyndamicin. The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14 days is as efficacious as any other rescue treatment, without the risk of selecting drug resistant strains.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 16, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 22, 2014
October 1, 2014
2.1 years
June 9, 2011
October 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late Parasitological Failure
Parasitaemia after day 3 in the absence of fever (axillary temperature \<37.5°C)
Day4-Day28
Secondary Outcomes (7)
PCR unadjusted efficacy
Day 28 days
Day 42 clinical efficacy
Day 42
Change in Fever clearance time (FCT)
Day 0, Day 1, Day 2
Change in Asexual parasite clearance time
Day 0, Day 1, Day 2
Hb changes
Day 0, Days 14 and Day 28
- +2 more secondary outcomes
Study Arms (3)
Artemether/Lumefantrine
EXPERIMENTALTablets 20 mg/120 of Artemether/Lumefantrine will be given to 124 trial patients
Artesunate/Amodiaquine
EXPERIMENTALTablets 25mg/67,5 mg of Artesunate/Amodiaquine will be given to 124 trial patients.
Quinine + Clindamycin
ACTIVE COMPARATORQuinine tablet 125mg + Clindamycin syrup 75mg/5ml will be given to 60 children.
Interventions
Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk). Weight in kg Number of tablet per dose Age 5 to \< 15 kg 1 tablet per dose 15 to \< 25 kg 2 tablets per dose 25 to \< 35 kg 3 tablets per dose
Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to \< 9kg):1 tablet (25 mg/675mg) for 3 days 1 to 5 years (= 9 kg to \< 18 kg)1 tablet(25mg/67,5mg)for 3 days
this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow; Quinine: 9 to \< 11 kg: ½ tablets 12 to \< 19 kg: 1 tablets per dose 20 to \< 27 kg: 1½ tablets per dose 28 to \< 35 kg: 2 tablets per dose Clindamycin syrup: 10 mg/kg twice daily
Eligibility Criteria
You may qualify if:
- Have been enrolled in the first phase
- Recurrent Plasmodium falciparum infection with clinical symptoms.
- Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the study.
- Signed (or thumb-printed whenever parents/guardians are illiterate) (second) informed consent by the parents or guardians. Note: the informed consent will cover the whole period of the study, including additional active follow ups
You may not qualify if:
- Patients with at least one of the following criteria will be excluded:
- Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
- Known hypersensitivity and previous Serious Adverse Events related to the study drugsto the study drugs.
- Severe malaria( WHO 2000) or danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand.
- Presence of intercurrent illness or any condition (cardiac, renal, hematologic, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
- Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent).
- Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
- Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- European and Developing Countries Clinical Trials Partnership (EDCTP)collaborator
- Fund for Scientific Research, Flanders, Belgiumcollaborator
- Institute of Tropical Medicine, Belgiumcollaborator
- University of Kinshasacollaborator
- Centre Murazcollaborator
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- Makerere Universitycollaborator
Study Sites (2)
Centre de Santé Lisungi
Kinshasa, Mont-Ngafula, Route Kimwenza n°23, Republic of the Congo
Kazo Health centre IV
Kiruhura, P.O Box 5 Rushere, Uganda
Related Publications (3)
Mavoko HM, Nabasumba C, da Luz RI, Tinto H, D'Alessandro U, Kambugu A, Baraka V, Rosanas-Urgell A, Lutumba P, Van Geertruyden JP. Efficacy and safety of re-treatment with the same artemisinin-based combination treatment (ACT) compared with an alternative ACT and quinine plus clindamycin after failure of first-line recommended ACT (QUINACT): a bicentre, open-label, phase 3, randomised controlled trial. Lancet Glob Health. 2017 Jan;5(1):e60-e68. doi: 10.1016/S2214-109X(16)30236-4. Epub 2016 Nov 11.
PMID: 27840069DERIVEDMuhindo Mavoko H, Kalabuanga M, Delgado-Ratto C, Maketa V, Mukele R, Fungula B, Inocencio da Luz R, Rosanas-Urgell A, Lutumba P, Van Geertruyden JP. Uncomplicated Clinical Malaria Features, the Efficacy of Artesunate-Amodiaquine and Their Relation with Multiplicity of Infection in the Democratic Republic of Congo. PLoS One. 2016 Jun 9;11(6):e0157074. doi: 10.1371/journal.pone.0157074. eCollection 2016.
PMID: 27280792DERIVEDMuhindo Mavoko H, Nabasumba C, Tinto H, D'Alessandro U, Grobusch MP, Lutumba P, Van Geertruyden JP. Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial. Trials. 2013 Sep 23;14:307. doi: 10.1186/1745-6215-14-307.
PMID: 24059911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hypolite M. Mavoko, MD MPH
Kinshasa University, RDCongo
- PRINCIPAL INVESTIGATOR
Carolyn Nabasumba, M.B.Ch.B
Kazo health centre IV Uganda
- STUDY DIRECTOR
Jean-Pierre Van geertruyden, MD MPH PhD
International Health Unit Antwerp university
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 16, 2011
Study Start
May 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 22, 2014
Record last verified: 2014-10