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

NCT03431714 | Completed Phase 4

• 1 other identifier: NIMR-Tanzania
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

• Adequate clinical response

  Proportions of patients with 100% cure before PCR correction

  28 days

Secondary Outcomes (1)

• PCR corrected responses

  one months after study completion

Study Arms (1)

single arm

EXPERIMENTAL

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

Interventions

Artesunate amodiaquine DRUG

Drugs were administered under observation of the study nurse for three days

Also known as: dihydroartemisinin piperaquine

single arm

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• World Health Organization: collaborator

Study Sites (1)

National Institute for Medical Research

Tanga, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 30909922 DERIVED

MeSH Terms

Interventions

amodiaquine, artesunate drug combination

Study Officials

• Deus S Ishengoma, PhD

  National Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: February 13, 2018
• Study Start: July 14, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)