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

Sponsor

National Institute for Medical Research, Tanzania (Other)

Overall Status

Completed

CT.gov ID

NCT03431714

Collaborator

Muhimbili University of Health and Allied Sciences (Other), World Health Organization (Other)

333

Enrollment

Location

Arm

4.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Falciparum Malaria	Drug: Artesunate amodiaquine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

333 participants

Allocation:

N/A

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 concurrentlyThe 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 :

Jul 14, 2017

Actual Primary Completion Date :

Dec 8, 2017

Actual Study Completion Date :

Dec 8, 2017

Arms and Interventions

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 Names: dihydroartemisinin piperaquine

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 Names:

dihydroartemisinin piperaquine

Outcome Measures

Primary Outcome Measures

Adequate clinical response [28 days]
Proportions of patients with 100% cure before PCR correction

Secondary Outcome Measures

PCR corrected responses [one months after study completion]
Proportions of patients with 100% cure after PCR correction

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 10 Years

Sexes Eligible for Study:

All

Accepts 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);