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Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria (QuinAct)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374581
First Posted: June 16, 2011
Last Update Posted: October 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Fund for Scientific Research, Flanders, Belgium
Institute of Tropical Medicine, Belgium
University of Kinshasa
Centre Muraz
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Makerere University
Information provided by (Responsible Party):
Jean-Pierre Van geertruyden, Universiteit Antwerpen
  Purpose

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.


Condition Intervention Phase
Malaria Drug: Artemether/Lumefantrine Drug: Artesunate/Amodiaquine Drug: Quinine + Clindamycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jean-Pierre Van geertruyden, Universiteit Antwerpen:

Primary Outcome Measures:
  • Late Parasitological Failure [ Time Frame: Day4-Day28 ]
    Parasitaemia after day 3 in the absence of fever (axillary temperature <37.5°C)


Secondary Outcome Measures:
  • PCR unadjusted efficacy [ Time Frame: Day 28 days ]
    Proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping.

  • Day 42 clinical efficacy [ Time Frame: Day 42 ]
    All clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes ETF and LCF following WHO criteria.

  • Change in Fever clearance time (FCT) [ Time Frame: Day 0, Day 1, Day 2 ]
    The time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C.

  • Change in Asexual parasite clearance time [ Time Frame: Day 0, Day 1, Day 2 ]

    Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide.

    5. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment.


  • Hb changes [ Time Frame: Day 0, Days 14 and Day 28 ]
    Variation in Hb level between two measurements.

  • Early Treatment Failure [ Time Frame: Day0-Day3 ]
    Development of danger signs or severe malaria on Day 0, Day 1 Day 2 or Day 3, in the presence of parasitaemia Parasite density on Day 2 > Day 0 count, irrespective of axillary temperature Presence of parasitaemia on Day 3 with fever (axillary temperature ≥ 37.5°C) Parasitaemia on Day 3 ≥ 25 % of count on Day 0.

  • Late Clincial Failure [ Time Frame: Day0-Day28 ]
    Development of danger signs or severe malaria after Day 3 in the presence of parasitaemia Presence of parasitaemia and fever on any day from Day 4 to Day 28


Enrollment: 2117
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artemether/Lumefantrine
Tablets 20 mg/120 of Artemether/Lumefantrine will be given to 124 trial patients
Drug: Artemether/Lumefantrine

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

Other Name: Coartem®
Experimental: Artesunate/Amodiaquine
Tablets 25mg/67,5 mg of Artesunate/Amodiaquine will be given to 124 trial patients.
Drug: Artesunate/Amodiaquine

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

Other Name: Co-arsucam®
Active Comparator: Quinine + Clindamycin
Quinine tablet 125mg + Clindamycin syrup 75mg/5ml will be given to 60 children.
Drug: Quinine + Clindamycin

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

Other Names:
  • Quinimax® tablet 125mg
  • Dalacin® syrup 75mg/5ml

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have been enrolled in the first phase
  2. Recurrent Plasmodium falciparum infection with clinical symptoms.
  3. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the study.
  4. 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

Exclusion Criteria:

Patients with at least one of the following criteria will be excluded:

  1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
  2. Known hypersensitivity and previous Serious Adverse Events related to the study drugsto the study drugs.
  3. 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.
  4. 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.
  5. Patients who are taking drug which may prolong the QT (imidazole and triazole, antifungal agent).
  6. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
  7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374581


Locations
Congo
Centre de Santé Lisungi
Kinshasa, Mont-Ngafula, Congo, Route Kimwenza n°23
Uganda
Kazo Health centre IV
Kiruhura, Uganda, P.O Box 5 Rushere
Sponsors and Collaborators
Universiteit Antwerpen
European and Developing Countries Clinical Trials Partnership (EDCTP)
Fund for Scientific Research, Flanders, Belgium
Institute of Tropical Medicine, Belgium
University of Kinshasa
Centre Muraz
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Makerere University
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Pierre Van geertruyden, Prof, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01374581     History of Changes
Other Study ID Numbers: UA-IHU-2010-01 version 1
First Submitted: June 9, 2011
First Posted: June 16, 2011
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by Jean-Pierre Van geertruyden, Universiteit Antwerpen:
retreatment
artemisinin-based combination
malaria
resistant

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Artemisinins
Amodiaquine
Quinine
Artemether-lumefantrine combination
Clindamycin palmitate
Clindamycin phosphate
Artemisinine
Clindamycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Muscle Relaxants, Central
Physiological Effects of Drugs