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Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania (GF-TES-2017)

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.
ClinicalTrials.gov Identifier: NCT03431714
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Muhimbili University of Health and Allied Sciences
World Health Organization
Information provided by (Responsible Party):
Dr. Celine Mandara, National Institute for Medical Research, Tanzania

Brief Summary:
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.

Condition or disease Intervention/treatment Phase
Uncomplicated Falciparum Malaria Drug: Artesunate amodiaquine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The first group of 88 children were recruited first and given dihydroartemisinin- piperaquine, once the sample size was attained, the second group for artesunate amodiaquine followed and the follow-up for the two groups were running concurrently
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: single arm
Artesunate amodiaquine tablets containing 25/67.5 mg, 50/135mg and 100/270 mg base of artesunate-amodiaquine were administered according to body weight Dihrdroartemisinin piperaquine tablets containing 160/20mg and 320/40mg base of piperaquine dihydroartemisinin were administered according to body weight
Drug: Artesunate amodiaquine
Drugs were administered under observation of the study nurse for three days
Other Name: dihydroartemisinin piperaquine




Primary Outcome Measures :
  1. Adequate clinical response [ Time Frame: 28 days ]
    Proportions of patients with 100% cure before PCR correction


Secondary Outcome Measures :
  1. PCR corrected responses [ Time Frame: one months after study completion ]
    Proportions of patients with 100% cure after PCR correction



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 6 months to 10 years.
  • mono-infection with P. falciparum detected by microscopy;
  • parasitaemia of 250 - 200,000/μl asexual forms;
  • presence of axillary temperature ≥37.5 °C or history of fever during the past 24 hours
  • ability to swallow oral medication;
  • ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
  • Informed consent from the parents or guardians of children.

Exclusion Criteria:

  • mRDT negative
  • presence of general danger signs in children aged 6 months to 10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
  • weight under 5 Kg
  • mixed or mono-infection with another Plasmodium species detected by microscopy;
  • presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm in children ≤ 59 months; or BMI of <16 in children aged 5 years and above)
  • presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
  • regular medication, which may interfere with antimalarial pharmacokinetics;
  • history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

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): NCT03431714


Locations
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Tanzania
National Institute for Medical Research
Tanga, Tanzania
Sponsors and Collaborators
National Institute for Medical Research, Tanzania
Muhimbili University of Health and Allied Sciences
World Health Organization
Investigators
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Principal Investigator: Deus S Ishengoma, PhD National Institute for Medical Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Celine Mandara, Researcher, National Institute for Medical Research, Tanzania
ClinicalTrials.gov Identifier: NCT03431714     History of Changes
Other Study ID Numbers: NIMR-Tanzania
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Piperaquine
Amodiaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics