Clinical trial NCT03431714: Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Official title: Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated Falciparum Malaria
Lead sponsor: National Institute for Medical Research, Tanzania
Sponsor class: OTHER_GOV
Collaborators: name: Muhimbili University of Health and Allied Sciences
name: World Health Organization
First posted: 2018-02-13
Enrollment: 333
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.


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);

Primary outcomes:
measure: Adequate clinical response
timeFrame: 28 days
Secondary outcomes:
measure: PCR corrected responses
timeFrame: one months after study completion
Other outcomes:
Locations:
city: Tanga
country: Tanzania
facility: National Institute for Medical Research
Study officials:
affiliation: National Institute for Medical Research
name: Deus S Ishengoma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.