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

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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

Tracking Information
First Submitted Date  ICMJE December 22, 2017
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE July 14, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Adequate clinical response [ Time Frame: 28 days ]
Proportions of patients with 100% cure before PCR correction
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
PCR corrected responses [ Time Frame: one months after study completion ]
Proportions of patients with 100% cure after PCR correction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Official Title  ICMJE Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Uncomplicated Falciparum Malaria
Intervention  ICMJE Drug: Artesunate amodiaquine
Drugs were administered under observation of the study nurse for three days
Other Name: dihydroartemisinin piperaquine
Study Arms  ICMJE 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
Intervention: Drug: Artesunate amodiaquine
Publications * Mandara CI, Francis F, Chiduo MG, Ngasala B, Mandike R, Mkude S, Chacky F, Molteni F, Njau R, Mohamed A, Warsame M, Ishengoma DS. High cure rates and tolerability of artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Kibaha and Kigoma, Tanzania. Malar J. 2019 Mar 25;18(1):99. doi: 10.1186/s12936-019-2740-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2018)
333
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 8, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03431714
Other Study ID Numbers  ICMJE NIMR-Tanzania
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Celine Mandara, National Institute for Medical Research, Tanzania
Study Sponsor  ICMJE National Institute for Medical Research, Tanzania
Collaborators  ICMJE
  • Muhimbili University of Health and Allied Sciences
  • World Health Organization
Investigators  ICMJE
Principal Investigator: Deus S Ishengoma, PhD National Institute for Medical Research
PRS Account National Institute for Medical Research, Tanzania
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP