Use of triple combination for falciparum malaria

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/09/009594
• Date of registration: 01-09-2017
• Prospective Registration: No
• Primary sponsor: UK Department for International Development DFID
• Public title: Use of triple combination for falciparum malaria
• Scientific title: A multi-centre, open-label randomised trial to assess the effi-cacy, safety and tolerability of Triple Artemisinin-based Combination Therapies (TACTs) compared to Artemisinin-based Combination Therapies (ACTs) in uncomplicated fal-ciparum malaria and to map the geographical spread of artemisinin and partner drug resistance.
• Date of first enrolment: 12-06-2016
• Target sample size: 1560
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15207
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

Bangladesh, Cambodia, Democratic Republic of the Congo, India, Myanmar, Thailand, Viet Nam

Contacts

• Name: Dr Neena Valecha
• Affiliation: National Institute of Malaria Research

• Name: Dr Anup Anvikar
• Affiliation: National Institute of Malaria Research

Key inclusion & exclusion criteria

Inclusion criteria: Acute uncomplicated P. falciparum malaria confirmed by positive blood smear with asexual forms of P. falciparum

Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, determined on a thin or thick blood film

Fever defined as > 37.5°C tympanic temperature or a history of fever within the last 24 hours

Written informed consent (by parent/guardian in case of chil-dren)

Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study


Exclusion criteria: Signs of severe/complicated malaria

Haematocrit < 25% or Hb < 8 g/dL at enrollment

Acute illness other than malaria requiring treatment

For females: pregnancy, breast feeding

Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days

Antimalarial therapy in past Two months

Previous splenectomy

Documented or claimed history of cardiac conduction prob-lems

Earlier participation within the TRACII trial or another trial in the previous 3 months.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Male or female aged 6 months to 65 years old with Acute uncomplicated P falciparum malaria

Intervention(s)

Intervention1: Artemether-lumefantrine AL
plus
Amodiaquine AQ
Primaquine PQ

: Day 1 AL Oral tab 3.4/24 mg/kg/day plus AQ 10mg /kg/day

Day 2 AL Oral tab 3.4/24 mg/kg/day plus
AQ 10 mg/kg/day
Day 3 AL Oral tab 3.4/24 mg/kg/day plus AQ 10mg /kg/day
PQ 0.75 mg base/kg as per who guildlines

Control Intervention1: Artemether Lumifanthrine AL
Primaquine PQ: Day1 Oral tablets AL 3.4/24 mg/kg/day

Day 2 Oral tablets AL 3.4/24 mg/kg/
Day 3Oral tablets AL 3.4/24 mg/kg/
Primaquine oral tablets 0.75mg base/kg as per WHO guidelines

Primary Outcome(s)

Endpoint 42 day PCR corrected efficacy defined as adequate clinical and parasitolog-ical response (ACPR). WHO definition: absence of parasitaemia at day 42 irrespective of axillary temperature and without previously meeting any of the WHO criteria for early or late treatment failure, or late parasitological failure.Timepoint: 42 days

Secondary Outcome(s)

Parasite clearance half-life assessed by microscopy

Fever clearance time

Incidence of adverse events and serious adverse events by study arms within the first 42 days.

Incidence of prolongation of the Qtc-interval above 500 ms or 30ms above baseline values.

Prevalence of Kelch13 mutations

Timepoint: 42 days

Source(s) of Monetary Support

NA

Ethics review

Status: Approved
Approval date: 16/01/2015
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 30/03/2015
Contact:

Institutional Ethics Committee

Status: Approved
Approval date: 20/04/2015
Contact:

Institutional Review Board

Status: Approved
Approval date: 04/06/2015
Contact:

Institutional Ethics Committee for clinical studies