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Trial record 22 of 48 for:    ( Map: Gabon )

Relapses in Plasmodium Ovale and Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria (REPLAMO)

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ClinicalTrials.gov Identifier: NCT02528279
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Michael Ramharter, Albert Schweitzer Hospital

Brief Summary:

Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax.

Although the interest in research on malaria has increased during the last years, yet little research is conducted on the "neglected" malaria species P. ovale and P. malariae. P. ovale being first described in 1922, it still remains unclear whether it displays dormant pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread in Central Africa, it is important to explore whether additional intake of liver-active medication is really needed and on this account further research to investigating new treatment options with liver stage activity should be conducted.

While, due to widespread resistance, treatment recommendations for P. falciparum and mixed infections have switched from chloroquine to the safer applicable artemisinin-based combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further studies assessing alternative treatment options are largely missing.

Summing up the current situation for both topics shows the need for further research. Therefore this study aims to assess the evidence and characterize the frequency of relapses in P. ovale infections with respect to differences between its subspecies as well as the effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed infections.


Condition or disease Intervention/treatment Phase
Malaria Drug: Coartem Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Assessment of Relapse Characteristics of Plasmodium Ovale and Antimalarial Treatment Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria in Gabon
Study Start Date : October 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Coartem

Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations:

Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight > 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food.

Drug: Coartem

Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations:

Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight > 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food.





Primary Outcome Measures :
  1. Adequate clinical and parasitological response (WHO criteria for antimalarial drug trials) [ Time Frame: 28 days ]
    Adequate clinical and parasitological response on Day 28


Secondary Outcome Measures :
  1. Parasite clearance time [ Time Frame: 7 days ]
  2. Fever clearance time [ Time Frame: 7 days ]
  3. Reappearance of P. ovale parasitemia [ Time Frame: from day 29 - 2 years of follow up ]
    Evidence and characterization of duration and frequency of relapses due to Plasmodium ovale after day 28. This is a disctinct outcome measure from the primary outcome and will be presented seperately.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients older than 1 year
  • Presence of uncomplicated malaria infection confirmed by: fever or history of fever in the previous 3 days, and positive microscopy of P. malariae, P. ovale or mixed infection with parasite density > 10 - 200000/µl of blood
  • Residence in vicinity and no travel plans for the next 6 months
  • Written informed consent by the patient or the legal representative and where possible, patient assent will be sought. If the patient/parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations.

Exclusion Criteria:

  • Presence of P. falciparum monoinfection
  • Presence of severe malaria (clinical WHO criteria)
  • Presence of other febrile conditions
  • Known history of hypersensitivity, allergic or adverse reactions to artemether or lumefantrine
  • Intake of any antimalarials or antibiotics with known antimalarial activity in the past 72 hours
  • Intake of an 8-aminoquinoline antimalarial or atovaquone-proguanil in preceding 28 days
  • Pregnant women in first trimenon

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): NCT02528279


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné, Hôpital Albert Schweitzer
Lambaréné, Moyen-Ogooué, Gabon, 118
Centre de Recherches Médicales de Ngounié
Fougamou, Ngounié, Gabon, 113
Sponsors and Collaborators
Albert Schweitzer Hospital
Medical University of Vienna
Investigators
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Principal Investigator: Michael Ramharter, Prof. Centre de Recherches Médicales de Lambaréné

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Ramharter, Assoc. Prof., MD, MSc, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier: NCT02528279     History of Changes
Other Study ID Numbers: Rep001
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Michael Ramharter, Albert Schweitzer Hospital:
Plasmodium ovale
relapse
artemether-lumefantrine
mixed species malaria
non-falciparum malaria
Additional relevant MeSH terms:
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Malaria
Recurrence
Protozoan Infections
Parasitic Diseases
Disease Attributes
Pathologic Processes
Lumefantrine
Artemether
Artemether, Lumefantrine Drug Combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents