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

Uncomplicated Falciparum Malaria Clinical Trial

— GF-TES-2017  

Official title:

Efficacy and Safety of Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431714
• Other study ID #: NIMR-Tanzania
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2017
• Last updated: February 12, 2018
• Start date: July 14, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: February 2018
• Source: National Institute for Medical Research, Tanzania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

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);

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated Falciparum Malaria

Intervention

Drug:
• Artesunate amodiaquine
Drugs were administered under observation of the study nurse for three days

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research	Tanga

Sponsors (3)

Lead Sponsor	Collaborator
National Institute for Medical Research, Tanzania	Muhimbili University of Health and Allied Sciences, World Health Organization

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate clinical response	Proportions of patients with 100% cure before PCR correction	28 days
Secondary	PCR corrected responses	Proportions of patients with 100% cure after PCR correction	one months after study completion