Malaria
Conditions
Keywords
Parasite clearance, Treatment failure
Brief summary
Drug efficacy testing is one of the most important tasks that is routinely undertaken by the National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT) and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
Detailed description
Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
Interventions
DRUGArtemether-lumefantrine
Artemether-lumefantrine
DRUGDihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine
Sponsors
Ministry of Health and Social Welfare, Tanzania
World Health Organization
National Institute for Medical Research, Tanzania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 6 months - 10 years, without severe malnutrition and with a slide-confirmed mono-infection of P. falciparum, and asexual parasitemia between 250 - 200000 asexual parasites/µl will be included. * Other inclusion criteria will include, absence of dangers signs (see
Exclusion criteria
), axillary temperature \> 37.5oC or a history of fever within the past 24 hours and ability to swallow oral medications. * The ability and willingness to attend scheduled follow-up visits and an informed consent provided by parent or guardian will also be considered as important inclusion criteria without which a patient will not be enrolled into the study. * Patients shall not be excluded on the basis of reported prior treatment with other anti-malarial drugs other than DHA-PQ within the past 24 hours if they have fever (axillary temperature \> 37.50C) and parasitemia. * Patients should have stable residence within the catchment area throughout the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| parasitological cure on day 28 for ALu and 42 for DHA-PQ | 42 days | non-adjusted and adjusted by PCR to account for new infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| parasite clearance after 72 hours. | 72 hours | Microscope Blood slide for malaria reading 0 parasite. |
| parasitological cure on day 14 | 14 days | Microscope Blood slide for malaria reading 0 parasite. |
| extended parasitological cure on day 42 for ALu and 63 for DHA-PQ | 63 days | PCR and Microscope Blood slide for malaria parasitemia reading 0. |
| reduction in gametocyte carriage at day 14 and day 28 from the day 0 baseline, | 28 days | — |
| occurrence and severity of adverse events and genomic profile of P.falciparum. | 63 days | — |
| improvement in haemoglobin level at day 28 from the day 0 baseline | 28 days | — |
Countries
Tanzania
Outcome results
None listed