Malaria Paediatrics
Conditions
Interventions
Group one dihydroartemisinin piperaquine phosphate DHAPQ
Group one Artemeter Lumefantrine AL
Sponsors
Ahmed Abdulakeem
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) All patients between the age of 6 month and 59 months with signs and symptoms of acute uncomplicated malaria. (ii) Axillary temperature =37.5 ºC or history of fever during the past 24 hr. (iii) Ability to swallow oral medication. (iv) Microscopically confirmed asexual forms of P. falciparum with parasite density count of between 2000 and 200 000 parasites / µl. (v) Willingness of the parent/guardian to comply with protocol as regards the study visit schedule.
Exclusion criteria
Exclusion criteria: (i) Those having symptoms and signs of severe falciparum malaria. (ii) A febrile condition due to diseases other than malaria e.g. measles, acute lower respiratory tract infection. (iii) Patients having severe malnutrition. (iv) Patients with sickle cell anaemia. (v) History of use of medication such as erythromycin, azithromycin, clindamycin and Septrin that might interfere with antimalarial pharmacokinetics. (vi) History of hypersensitivity to any of the study drugs will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic outcomes will be classified according to WHO guidelines as follows: Early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), and adequate clinical and parasitological response (ACPR).6,7 ETF is defined as development of danger signs or severe malaria on days 1, 2 or 3 in the presence of parasitaemia, or parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature, or parasitaemia on day 3 with axillary temperature 37ºc, or parasitaemia on day 3> 25% of day 0 count irrespective of axillary temperature. LCF is the development of danger signs or severe malaria and/or axillary temperature 37.5ºC, on any day from day 4 to 14, in the presence of parasitaemia without previously meeting any of the criteria of ETF. LPF is said to occur when there is parasitaemia on day 14 and axillary temperature < 37.5ºC without previously meeting any of the criteria of ETF or LCF. Adequate Clinical and Parasitological Response ACPR is the absence of parasitaemia on day 14 irrespective of axillary temperature without previously meeting any of the criteria of ETF, LCF, LPF. ACPR will be the primary endpoint while | — |
Secondary
| Measure | Time frame |
|---|---|
| the comparison of fever clearance, parasite clearance and side effects of the three treatments will be the secondary endpoints. The Parasite Clearance Time is the time in hours from the first antimalarial dose till the first two consecutive thick blood films that are negative for asexual P. falciparum parasites after checking 200 oil immersion fields. Fever clearance time is the time in hours from the first antimalarial dose till the temperature first decreased to <37.5°C and remained below 37.5°C for 24 hours. | — |
Countries
Nigeria
Contacts
Public ContactSamuel Olowookere
Senior Lecturer and Consultant Family Physician
Outcome results
None listed