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Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar (AcoI)

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ClinicalTrials.gov Identifier: NCT03764527
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Zanzibar Malaria Control Programme
World Health Organization
Information provided by (Responsible Party):
Professor Anders Björkman, Karolinska Institutet

Brief Summary:

The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®.

Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.


Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Drug: Artemether-lumefantrine Drug: Coadministered Artesunate plus Amodiaquine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A comparative randomised study comparing oral treatment with AQ + AS and CO of uncomplicated falciparum malaria in children.
Masking: None (Open Label)
Masking Description: The AQ+AS (AA) group received their drugs under direct observation once daily for 3 days. The Coartem (CO) group received their drugs twice daily, the second (evening) dose also under supervision. Drug treatment was thus not be blinded.
Primary Purpose: Treatment
Official Title: Randomized Study of the Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate Plus Amodiaquine Coadministered for the Treatment of Uncomplicated Falciparum Malaria in Zanzibar
Actual Study Start Date : November 1, 2002
Actual Primary Completion Date : February 17, 2003
Actual Study Completion Date : February 17, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Artemether-lumefantrine (AL)
One tablet of artemether-lumefantrine (Coartem®) was administered twice daily for 3 days to children with a body weight of 9 to <15 kg, and 2 tablets were administered twice daily for 3 days to children with a body weight of >15 to 25 kg. All doses were taken under direct observation.
Drug: Artemether-lumefantrine
Two doses a day for 3 days, under supervision
Other Name: Coartem®

Active Comparator: Artesunate + Amodiaquine (AA)
Artesunate + amodiaquine (ASAQ) was administered as follows: 4 mg/kg body weight of artesunate plus 10 mg/kg body weight of amodiaquine once daily for 3 days under direct observation.
Drug: Coadministered Artesunate plus Amodiaquine
One dose a day for 3 days, under supervision




Primary Outcome Measures :
  1. PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine (AA) or Coartem® (CO) [ Time Frame: 42 days ]
    Comparing PCR adjusted parasitological cure rate (PCR-APCR) between the two treatment options up to day 42. Parasitological cure will be adjusted using PCR genotyping of msp2 marker. Recrudescence is defined as the presence of at least one matching allelic band, and reinfection as the absence of any matching allelic band on day 0 and day of recurring parasitaemia. Patients with recurrent parasitaemia having missing filter paper sample or negative PCR results will be considered uncertain with regards to PCR adjusted outcome.


Secondary Outcome Measures :
  1. Safety of treatment with Artesunate + Amodiaquine (AA) or Coartem® (CO): Proportion of subjects with adverse events [ Time Frame: 42 days ]
    Proportion of subjects with adverse events, including early vomiting and mean values of white blood cells (WBC) and neutrophils

  2. Parasite clearance [ Time Frame: 42 days ]
    Proportion of patients with microscopy detectable parasitaemia at each time point

  3. Gametocyte carriage [ Time Frame: 42 days ]
    Proportion of patients with microscopy detectable gametocytes at each time point

  4. Fever clearance [ Time Frame: 42 days ]
    Proportion of patients with fever at each time point

  5. Hemoglobin [ Time Frame: 42 days ]
    Mean and individual hemoglobin values at different time points during follow up

  6. Selection of mutations in P. falciparum related to the resistance of the study drugs [ Time Frame: 42 days ]
    Change in possible selections of mutations related to quinoline resistance. Percentage of pfcrt and pfmdr1 mutations on day 0 and day of recurrent infection.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Children age 6-59 months and body weight ≥6 kg (AQ+AS); 9-59 months and body weight ≥9 kg (AL)
  • Fever or history of fever in the preceding 24 hours
  • Parasitemia ≥2000 ≤200.000 parasites per µl
  • Informed consent given by the child's parent or other adult guardian

Exclusion Criteria:

  • Signs of severe malaria or other danger signs, such as: 1.Unconsciousness; 2. Not able to sit or stand; 3.Severe anaemia (Hb ≤ 5 g/dl); 4.Convulsions; 5. Shock (systolic BP<50 mmHg); 6. Not able to drink or breastfeed; 7. Vomiting 3 times or more the past 24 hrs
  • Other diseases associated with fever
  • History of allergy to test drugs
  • History of intake of any drugs other than paracetamol and aspirin within 3 days

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): NCT03764527


Sponsors and Collaborators
Professor Anders Björkman
Zanzibar Malaria Control Programme
World Health Organization
Investigators
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Principal Investigator: Abdullah Ali Zanzibar Malaria Control Programme

Publications of Results:
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Responsible Party: Professor Anders Björkman, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03764527     History of Changes
Other Study ID Numbers: Aco-study
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Keywords provided by Professor Anders Björkman, Karolinska Institutet:
Artemether-Lumefantrine
Coartem
Artesunate
Amodiaquine
Zanzibar

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Amodiaquine
Artemether, Lumefantrine Drug Combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics