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

Primary Purpose

Uncomplicated Falciparum Malaria

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
Artesunate amodiaquine
Sponsored by
National Institute for Medical Research, Tanzania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Falciparum Malaria

Eligibility Criteria

6 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

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);

Sites / Locations

  • National Institute for Medical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Adequate clinical response
Proportions of patients with 100% cure before PCR correction

Secondary Outcome Measures

PCR corrected responses
Proportions of patients with 100% cure after PCR correction

Full Information

First Posted
December 22, 2017
Last Updated
February 12, 2018
Sponsor
National Institute for Medical Research, Tanzania
Collaborators
Muhimbili University of Health and Allied Sciences, World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03431714
Brief Title
Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Acronym
GF-TES-2017
Official Title
Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute for Medical Research, Tanzania
Collaborators
Muhimbili University of Health and Allied Sciences, World Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Falciparum Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Artesunate amodiaquine
Other Intervention Name(s)
dihydroartemisinin piperaquine
Intervention Description
Drugs were administered under observation of the study nurse for three days
Primary Outcome Measure Information:
Title
Adequate clinical response
Description
Proportions of patients with 100% cure before PCR correction
Time Frame
28 days
Secondary Outcome Measure Information:
Title
PCR corrected responses
Description
Proportions of patients with 100% cure after PCR correction
Time Frame
one months after study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deus S Ishengoma, PhD
Organizational Affiliation
National Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Medical Research
City
Tanga
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30909922
Citation
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.
Results Reference
derived

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Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

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