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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03056391
Date of registration:	31/01/2017
Prospective Registration:	No
Primary sponsor:	Menzies School of Health Research
Public title:	Effect of Paracetamol on Renal Function in Plasmodium Knowlesi Malaria PACKNOW
Scientific title:	Effect of Paracetamol on Renal Function in Plasmodium Knowlesi Malaria: A Randomised Controlled Clinical Trial
Date of first enrolment:	October 2016
Target sample size:	360
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03056391
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Malaysia

Contacts

Name:	Daniel Cooper, MBChB
Address:
Telephone:
Email:
Affiliation:	Menzies School of Health Research

Name:	Bridget Barber, MBBS
Address:
Telephone:
Email:
Affiliation:	Menzies School of Health Research

Name:	Giri M Rajahram, MD
Address:
Telephone:
Email:
Affiliation:	Clinical Research Center, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia

Name:	Katherine Plewes, MD
Address:
Telephone:
Email:
Affiliation:	Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand

Name:	Tsin Yeo, MBBS
Address:
Telephone:
Email:
Affiliation:	Menzies School of Health Research

Name:	Arjen Dondorp, MD
Address:
Telephone:
Email:
Affiliation:	Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand

Name:	Jayaram Menon, MBBS
Address:
Telephone:
Email:
Affiliation:	Ministry of Health, Malaysia

Name:	Matthew Grigg, MBBS
Address:
Telephone:
Email:
Affiliation:	Menzies School of Health Research

Name:	Nicholas Anstey, PhD
Address:
Telephone:
Email:
Affiliation:	Menzies School of Health Research

Name:	Timothy William, MBBS
Address:
Telephone:
Email:
Affiliation:	Jesselton Medical Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient age = 5 years

2. Presence of P. knowlesi malaria, confirmed by positive blood smear with asexual forms
of P. knowlesi.

3. Temperature >38C on admission or fever during the preceding 48 hours

4. Enrolled within 18 hours of commencing antimalarial treatment

5. Written informed consent from patient or attending relative able to and willing to
give informed consent. Consent form and information sheets will be translated into
Malay and copies provided to the patient.

Exclusion Criteria:

1. Patient or relatives unable or unwilling to give informed consent

2. Contraindication or allergy to paracetamol or artesunate therapy

3. Known cirrhosis, or >6 standard alcoholic drinks/day

4. Pregnancy

Age minimum: 5 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Paracetamol

Primary Outcome(s)

Effect of Paracetamol on kidney function [Time Frame: 72 hours]

Secondary Outcome(s)

Development of AKI [Time Frame: 72 hours]

Longitudinal changes in haemolysis: plasma cell-free haem [Time Frame: 72 hours]

Change in creatinine (umol/L) between therapeutic concentrations of paracetamol vs those with absent or low. [Time Frame: 72 hours]

Longitudinal changes in markers of endothelial dysfunction [Time Frame: 72 hours]

Longitudinal urine pH [Time Frame: 72 hours]

Fever clearance time [Time Frame: 72 hours]

Fever duration [Time Frame: 72 hours]

Longitudinal red cell deformability [Time Frame: 72 hours]

Longitudinal changes in F2-IsoPs according to G6PD genotype [Time Frame: 72 hours]

Longitudinal changes in haemolysis: haem-to-protein cross-links [Time Frame: 72 hours]

Longitudinal changes in CFHb according to G6PD genotype [Time Frame: 72 hours]

Longitudinal changes in markers of oxidative stress: F2-IsoP [Time Frame: 72 hours]

Longitudinal changes in haemolysis: plasma cell-free haemoglobin [Time Frame: 72 hours]

Population pharmacodynamics of paracetamol [Time Frame: 72 hours]

Blood and urine biomarkers of pre-renal and renal injury [Time Frame: 72 hours]

Longitudinal change in creatinine [Time Frame: 72 hours]

Duration of AKI [Time Frame: 28 days]

Longitudinal urine specific gravity [Time Frame: 72 hours]

Longitudinal changes in CFHb according to G6PD enzyme activity [Time Frame: 72 hours]

Longitudinal changes in F2-IsoPs according to G6PD enzyme activity [Time Frame: 72 hours]

Longitudinal changes in markers of oxidative stress: IsoF [Time Frame: 72 hours]

Longitudinal urine haemoglobin [Time Frame: 72 hours]

Population pharmacokinetics of paracetamol: Cmax [Time Frame: 72 hours]

Population pharmacokinetics of paracetamol: Tmax [Time Frame: 72 hours]

Area above the fever versus time curve (AUC-T°) [Time Frame: 72 hours]

Longitudinal changes in IsoFs according to G6PD genotype [Time Frame: 72 hours]

Parasite clearance time (hours) [Time Frame: 72 hours]

Change in creatinine in severe malaria [Time Frame: 72 hours]

Longitudinal changes in IsoFs according to G6PD enzyme activity [Time Frame: 72 hours]

Longitudinal urine colour [Time Frame: 72 hours]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: 28 days]

Population pharmacokinetics of paracetamol: AUC [Time Frame: 72 hours]

Secondary ID(s)

NMRR-16-356-29088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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