Uncomplicated Malaria Clinical Trial
— TES2016Official title:
Efficacy and Safety of Artemether Lumefantrine for the Treatment of Uncomplicated Malaria in Tanzania
Verified date | February 2017 |
Source | National Institute for Medical Research, Tanzania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Following the development of drug resistance to antimalarial first line treatment of
uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health -
Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum
malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened
vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of
malaria. The decline of outpatient malaria cases in recent years and declining entomological
inoculation rates (EIR) that are currently being recorded in most areas that were before
considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift
in the epidemiology of malaria transmission in Tanzania. This current shift provides a new
and yet critical challenge with regards to assessment and monitoring of the efficacy of the
first-line treatment specifically considering that artemisinin resistance has been confirmed
in the Greater Mekong sub-region. The aim of the study was to set up a system for country
wide representative surveillance to obtain data of the safety and efficacy of AL following
countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was
conducted in the framework of the existing NMCP sentinel sites that are ecological
representative for malaria endemicity in Tanzania Objective: To assess the efficacy and
safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine
for the treatment of uncomplicated falciparum malaria in Tanzania.
Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha,
Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites
(Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the
second round to be undertaken in 2017.
Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016.
The results of this study will assist the Ministry of Health to monitor the efficacy and
safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for
assessing the current national treatment guidelines for uncomplicated falciparum malaria.
Status | Completed |
Enrollment | 344 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 10 Years |
Eligibility |
Inclusion Criteria: • Patients aged 6 months-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: - presence of general danger signs in children aged 6 months-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); - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute for Medical Research, Tanzania |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rates as per WHO protocol | number with ACPR | 28 days |
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