DHA Piperaquine for falciparum malaria in children and adolescent

Phase 3

Completed

• Conditions: Health Condition 1: null- Children and adolescent patietns with uncomplicated Plasmodium falciparum malaria

• Registration Number: CTRI/2017/11/010664
• Lead Sponsor: Medicines for Malaria Venture

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-17
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Male and Female paediatric patients aged from 6 months to less than 18 years

Ability to swallow oral tablets as whole or crushed tablets

Body weight more than and equal to 5 kg and less 100 kg

Acute uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum parasitaemia comprised between 80 and less than 100000 parasites per micro liter of blood

History of fever anytime during the preceding 24 hours or presence of fever axillary temperature more than 37.5 degree centigrate

Ability of parents or legally acceptable representative to understand the nature of the trial and providing signed informed consent. A child assent should also be obtained when the child is 7 years and older

Stable residence in the study area during the two months after recruitment and willingness to comply with the study protocol and the study visit schedule

Exclusion Criteria

Antimalarial treatment with amodiaquine chloroquine quinine or lumefantrine within the previous 6 weeks with piperaquine or mefloquine or sulphadoxine pyrimethamine within the previous 3 months and with halofantrine or other artemisinin based compounds within the 30 days prior to screening

Any other antimalarial treatment or antibiotics with antimalarial activity including cotrimoxazol and any herbal products within the 7 days prior to screening

Children below five years presenting severe malnutrition defined as weight for height less than 70 percent of the median NCHS WHO reference

Severe vomiting or dehydration

Presence of jaundice

Presence of intercurrent illness or any condition which in the Investigators judgement would place the patient at undue risk or interfere with the study results

Known hypersensitivity to the artemisinin based therapy or piperaquine

Clinical and or laboratory features of severe malaria according to WHO criteria

Known severe renal impairment or liver insufficiency

Moderate and severe anaemia Hb less 7 g per dL

Pregnant or lactating females

Female patients of child-bearing potential must be neither pregnant as demonstrated by a negative pregnancy test nor lactating and must be willing to take measures to not become pregnant during the study period

Participation in any investigational drug study during the 30 days prior to screening or previously enrolled in the present trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified