Severe MalariaPhase 3PROTECtSNCT04251351
Effect of Paracetamol on Kidney Function in Severe Malaria
A Phase 3 study testing Paracetamol and Mechanical antipyresis in people with Severe Malaria and Malaria,Falciparum, run by University of British Columbia at 1 site in Democratic Republic of the Congo.
Trial summary
A randomised open labeled, parallel-group, controlled trial to assess the efficacy of paracetamol to reduce kidney dysfunction caused by cell-free haemoglobin-mediated oxidative damage in paediatric patients with falciparum malaria complicated by intravascular haemolysis. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Severe Malaria, Malaria,Falciparum, Acute Kidney Injury
- What is being tested?
- Paracetamol and Mechanical antipyresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 13 Dec 2021to 1 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female, patients aged 1 to ≤ 14 years
- Severe P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or positive PfHRP2 rapid diagnostic test (RDT).
- Pre-specified modified criteria for severe falciparum malaria
- Upon hospital admission, asexual parasitaemia plus at least ONE of the following:
- Glasgow coma score < 11/15 or Blantyre coma score <3/5 in pre-verbal children
- Generalized convulsions (≥2 in 24 hours)
Show all 20Show fewer
- Jaundice (visible jaundice)
- Severe anaemia (HCT <15%/Hb<5 g/dL: aged <12) Severe anaemia (HCT <20%/Hb<7 g/dL: aged ≥12)
- Hyperparasitaemia (>10%)
- Hypoglycaemia (glucose < 2.2 mmol/L; <40 mg/dL)
- Kidney dysfunction (blood urea > 20 mmol/L)
- Acidosis (venous bicarbonate <15 mmol/L or base excess less than -3.3mEq/L)
- Venous lactate > 5 mmol/L
- Shock (systolic blood pressure < 70 mmHg (<12 years) <80 mmHg (≥12 years) with cool extremities or capillary refill >3 seconds)
- Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate>ULN for age)
- Spontaneous bleeding
- Prostration (inability to set upright, or drink)* Abbreviations: HCT, haematocrit; Hb, haemoglobin; *cannot be only severity criteria
- Temperature >38°C on admission or fever during the preceding 48 hours.
- Less than 24 hours of antimalarial therapy
- Attending caregiver of participant willing and able to give informed consent for participation in the study
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- Contraindication or known allergy to paracetamol
- Known chronic liver disease or tender hepatomegaly
- Known chronic kidney disease, history of renal replacement therapy or renal biopsy
- Participants who are already enrolled in another research trial involving an investigational product or have participated to the same study before
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
The Kinshasa Medical Oxford Research Unit (KIMORU)
Kinshasa, Congo
Marie Onyamboko, Dr., +243990024201, akatshimarie@yahoo.fr
Caterina Fanello, Dr., +447900278768, caterina.fanello@ndm.ox.ac.uk
About this study
Official title: Evaluating the Renoprotective Effect of Paracetamol in Paediatric Severe Malaria: a Randomised Controlled Trial
A randomised open labeled, parallel-group, controlled trial to assess the efficacy of paracetamol to reduce kidney dysfunction caused by cell-free haemoglobin-mediated oxidative damage in paediatric patients with falciparum malaria complicated by intravascular haemolysis.
Read the detailed description
Kidney dysfunction is an independent predictor of mortality in both adults and children with severe malaria. In the largest studies of paediatric severe malaria, approximately 25% of children had kidney dysfunction and these patients accounted for roughly 50% of total deaths.
Although the multifactorial mechanism of severe malaria-associated AKI has primarily been studied in adults, evidence suggests that similar mechanisms of renal injury are involved in paediatric severe malaria. Cell-free haemoglobin (CFH) -mediated oxidative damage has recently been recognized as an important pathway in a range of common conditions, including rhabdomyolysis, primary pulmonary graft dysfunction, and haemolytic disorders, such as post-cardiac surgery, and malaria. During malaria infection, there is haemolysis of parasitized and uninfected red blood cells (RBCs). CFH-mediated lipid peroxidation generates F2-isoprostanes (F2-IsoPs) and isofurans (IsoFs), which are considered robust in vivo measures of oxidative stress. F2-IsoPs are potent renal vasoconstrictors that act via thromboxane A2 receptors. Both F2-IsoPs and IsoFs have been associated with AKI in patients with rhabdomyolysis, sepsis, adults with severe malaria and haemolysis post-cardiopulmonary bypass (CPB). Further, elevated haemin and CFH concentrations were associated with mortality. In a cohort of children with severe malaria, elevated haem-to-haemopexin ratio was associated with stage 3 AKI, and 6-month mortality. These studies demonstrate that intravascular haemolysis occurs with increasing severity in paediatric malaria. Haem redox cycling between ferric (Fe3+) and ferryl (Fe4+) states generates globin radicals, inducing lipid peroxidation. These data suggested that haemolysis induces oxidative damage, and CFH-mediated oxidative damage contributes to AKI complicating paediatric malaria.
A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol acts as a potent inhibitor of haemoprotein-catalyzed lipid peroxidation, by reducing ferryl haem to its less toxic ferric state and quenching globin radicals. We hypothesize that this novel inhibitory mechanism of paracetamol may provide renal protection in children with severe malaria by reducing the haemoprotein-induced lipid peroxidation. As there is currently no consensus that exists concerning adequate medical treatment for severe malaria complicated by intravascular haemolysis and AKI, the potential application of this safe and extensively used drug would be of great benefit.
The study will be a randomised, open-labelled, controlled trial. Randomisation will be stratified into two groups : (i) Patients with no acute kidney injury (AKI) at enrolment, and (ii) Patients with AKI at enrolment. Both groups will be randomised into two arms: Arm 1: Paracetamol 15 mg/kg/dose 6 hourly for 72 hours Arm 2: Mechanical antipyresis if fever in the first 72 hours. All patients will receive intravenous artesunate followed by artemether-lumefantrine as soon as they are able to take oral medication or according to medical judgment.
The study will be conducted at the Kinshasa Medical Oxford Research Unit (KIMORU, Democratic Republic of the Congo, DRC). The recruitment phase of the study is expected to last 18 months, from September 2021 - February 2022. The total time to complete the study will be approximately 3 years.
Funder: Canadian Institutes of Health Research
CIHR grant reference number : PJT-162116
UBC grant number: 20R01487
- Conditions
- Severe Malaria, Malaria,Falciparum, Acute Kidney Injury, Paracetamol
- Being tested
- Paracetamol, Mechanical antipyresis
- Keywords
- Severe Malaria, Falciparum, Paracetamol, Renoprotection, Acute Kidney Injury
- Medical subject headings
- Malaria, Malaria, Falciparum, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetyl-Para-Aminophenol (APAP), Acetaminophen
Paracetamol 15 mg/kg/dose IV 6 hourly for 72 hours
Mechanical antipyresisProcedure or surgery
Mechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours.
If a temperature >38.5°C persists despite mechanical antipyresis, or if deemed necessary by the treating clinician, then paracetamol can be administered according to local practice (paracetamol IV 15 mg/kg as needed).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Paracetamol 15 mg/kg/dose 6 hourly for 72 hours Receives: Drug: Paracetamol |
| Arm 2 | Sham comparator | Mechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours. Receives: Procedure: Mechanical antipyresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome)
Composite outcome of development of AKI (defined as creatinine ≥26.5 µmol/L or ≥1.5x baseline), or death at any timepoint
Measured: during first 7 days of enrolment
Acute kidney injury (AKI) progression or death among patients enrolled with AKI (Composite outcome)
Composite outcome of worsening of AKI (defined as creatinine ≥2x baseline, or ≥3x baseline, or initiation of RRT or eGFR <35 ml/min/ 1.73 m2) or death at any timepoint.
Measured: during first 7 days of enrolment
Secondary outcomes (21)
Number of patients with serious adverse events
Number of patients with serious adverse events (mortality and/or hepatotoxicity, as defined by Hy's Law).
Measured: AST/ALT/total bilirubin during the first 5 days from enrolment; mortality assessed Day 0 to 7.
Proportion of patients who develop Major Adverse Kidney Events (MAKE) composite
Major Adverse Kidney Events (MAKE) composite, defined as ≥ 1 efficacy renal endpoints: (i) death, (ii) need for renal replacement therapy, (iii)≥ 50% reduction in eGFR from baseline to 90 days.
Measured: 90 days
Fever clearance time
Time taken for aural temperature: (i) to fall < 37.5°C (FCT-A), and (ii) to fall < 37.5°C and remain there for >24 h (FCT-B)
Measured: 6-hourly temperature assessments during first 7 days from enrolment
Coma recovery
Time until Glasgow Coma Score (GCS) return to 15 (or Blantyre Coma Score (BCS) return to 5 in preverbal children)
Measured: 6-hourly GCS/BCS assessments during first 7 days from enrolment
Longitudinal change in renal function
As measured by creatinine concentration (umol/L)
Measured: During the first 7 days from enrolment
Longitudinal change in markers of hemolysis
As measured by cell-free haemoglobin (ug/mL), haemopexin (ug/mL), haptoglobin (ug/mL), haem (uM), F2-isoprostane (pg/mL) and isofurans (pg/mL) concentrations
Measured: during the first 3 days from enrolment
Longitudinal change of endothelial activation
As measured by concentrations of angiopoietin-Tie2 pathway markers (i.e. Ang-1, Ang-2, sTie2, sTie1)
Measured: during the first 3 days from enrolment
Longitudinal change of immune activation
As measured by soluble triggering receptor expressed on myeloid cells concentration (sTREM-1; pg/mL)
Measured: during the first 3 days from enrolment
Longitudinal change of AKI biomarker
As measured by cystatin-C concentration (Cys-C; ug/mL)
Measured: during the first 3 days from enrolment
Parasite (parasites/ul) clearance
as measured by time until two consecutive negative smears (hours), and by rate using the parasite clearance estimator to determine slope half-life (hours) from 12-hourly parasite counts.
Measured: 12-hourly parasitemia assessments during first 7 days from enrolment
Exploratory analysis with sex
Primary efficacy analyses will be analysed using a logistic regression model to obtain odds ratios, comparing the odds of a combined endpoint of kidney function deterioration or death between treatment groups. A multivariable model including an interaction term (sex and treatment) will be assessed in the primary analyses to explore potential differences between males and females.
Measured: During first 7 days from enrolment
Pharmacokinetic properties
Population pharmacokinetic model (relative bioavailability, mean transit absorption time (hours), apparent oral elimination clearance (L/hours), apparent volume of distribution (L)
Measured: during the first 24 hours from enrolment
Pharmacokinetic properties
Peak plasma concentration (Cmax; mg/L)
Measured: during the first 24 hours from enrolment
Pharmacokinetic properties
Time to peak plasma concentration (Tmax; hours)
Measured: during the first 24 hours from enrolment
Pharmacokinetic properties
Terminal elimination (t1/2; hours)
Measured: during the first 24 hours from enrolment
Pharmacokinetic properties
Area under the plasma drug concentration-time curve (AUC0-24; mg×h×L-1)
Measured: during the first 24 hours from enrolment
Pharmacodynamic relationships
Pharmacodynamic effects on creatinine concentration (mol/L)
Measured: during first 7 days from enrolment
Pharmacodynamic relationships
Pharmacodynamic effects on liver toxicity, as measured by AST and ALT (U/L)
Measured: during first 7 days from enrolment
Pharmacodynamic relationships
Pharmacodynamic effects on temperature (Celsius)
Measured: during first 7 days from enrolment
Pharmacodynamic relationships
Pharmacodynamic effects on parasitemia, as measured by parasites/ul and slope half-life
Measured: during first 7 days from enrolment
Pharmacodynamic relationships
Pharmacodynamic effects on GCS (or BCS in pre-verbal children)
Measured: during first 7 days from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start13 Dec 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalariaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prior to randomization, participants will be stratified into two groups: (i) Patients with no acute kidney injury (AKI) at enrolment, and (ii) Patients with AKI at enrolment. Both groups will be randomised into two arms: Arm 1: Paracetamol 15 mg/kg/dose 6 hourly for 72 hours Arm 2: Mechanical antipyresis
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Kinshasa Medical Oxford Research Unit
- Responsible party
- Principal investigator, Katherine Plewes, MD PhD, University of British Columbia
- Investigators
- Katherine Plewes, Dr., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251351
- Sponsor's protocol ID
- H19-03570
- Acronym
- PROTECtS
- Status last verified
- Jun 2023
- First submitted
- 17 Dec 2019
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. Datasets will be de-identified to ensure patient privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Renoprotective Effect of Paracetamol in Paediatric Severe Malaria: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04251351
- Acronym / sponsor ID
- PROTECtS / H19-03570
- Conditions
- Severe Malaria, Malaria,Falciparum, Acute Kidney Injury, Paracetamol
- Keywords
- Severe Malaria, Falciparum, Paracetamol, Renoprotection, Acute Kidney Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Kinshasa Medical Oxford Research Unit
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised open labeled, parallel-group, controlled trial to assess the efficacy of paracetamol to reduce kidney dysfunction caused by cell-free haemoglobin-mediated oxidative damage in paediatric patients with falciparum malaria complicated by intravascular haemolysis.
Detailed description
Kidney dysfunction is an independent predictor of mortality in both adults and children with severe malaria. In the largest studies of paediatric severe malaria, approximately 25% of children had kidney dysfunction and these patients accounted for roughly 50% of total deaths.
Although the multifactorial mechanism of severe malaria-associated AKI has primarily been studied in adults, evidence suggests that similar mechanisms of renal injury are involved in paediatric severe malaria. Cell-free haemoglobin (CFH) -mediated oxidative damage has recently been recognized as an important pathway in a range of common conditions, including rhabdomyolysis, primary pulmonary graft dysfunction, and haemolytic disorders, such as post-cardiac surgery, and malaria. During malaria infection, there is haemolysis of parasitized and uninfected red blood cells (RBCs). CFH-mediated lipid peroxidation generates F2-isoprostanes (F2-IsoPs) and isofurans (IsoFs), which are considered robust in vivo measures of oxidative stress. F2-IsoPs are potent renal vasoconstrictors that act via thromboxane A2 receptors. Both F2-IsoPs and IsoFs have been associated with AKI in patients with rhabdomyolysis, sepsis, adults with severe malaria and haemolysis post-cardiopulmonary bypass (CPB). Further, elevated haemin and CFH concentrations were associated with mortality. In a cohort of children with severe malaria, elevated haem-to-haemopexin ratio was associated with stage 3 AKI, and 6-month mortality. These studies demonstrate that intravascular haemolysis occurs with increasing severity in paediatric malaria. Haem redox cycling between ferric (Fe3+) and ferryl (Fe4+) states generates globin radicals, inducing lipid peroxidation. These data suggested that haemolysis induces oxidative damage, and CFH-mediated oxidative damage contributes to AKI complicating paediatric malaria.
A novel mechanism of paracetamol was recently demonstrated, showing that paracetamol acts as a potent inhibitor of haemoprotein-catalyzed lipid peroxidation, by reducing ferryl haem to its less toxic ferric state and quenching globin radicals. We hypothesize that this novel inhibitory mechanism of paracetamol may provide renal protection in children with severe malaria by reducing the haemoprotein-induced lipid peroxidation. As there is currently no consensus that exists concerning adequate medical treatment for severe malaria complicated by intravascular haemolysis and AKI, the potential application of this safe and extensively used drug would be of great benefit.
The study will be a randomised, open-labelled, controlled trial. Randomisation will be stratified into two groups : (i) Patients with no acute kidney injury (AKI) at enrolment, and (ii) Patients with AKI at enrolment. Both groups will be randomised into two arms: Arm 1: Paracetamol 15 mg/kg/dose 6 hourly for 72 hours Arm 2: Mechanical antipyresis if fever in the first 72 hours. All patients will receive intravenous artesunate followed by artemether-lumefantrine as soon as they are able to take oral medication or according to medical judgment.
The study will be conducted at the Kinshasa Medical Oxford Research Unit (KIMORU, Democratic Republic of the Congo, DRC). The recruitment phase of the study is expected to last 18 months, from September 2021 - February 2022. The total time to complete the study will be approximately 3 years.
Funder: Canadian Institutes of Health Research
CIHR grant reference number : PJT-162116
UBC grant number: 20R01487
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prior to randomization, participants will be stratified into two groups: (i) Patients with no acute kidney injury (AKI) at enrolment, and (ii) Patients with AKI at enrolment. Both groups will be randomised into two arms: Arm 1: Paracetamol 15 mg/kg/dose 6 hourly for 72 hours Arm 2: Mechanical antipyresis
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: ParacetamolParacetamol 15 mg/kg/dose 6 hourly for 72 hours |
| Arm 2 | Sham comparator | Procedure: Mechanical antipyresisMechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Male or Female, patients aged 1 to ≤ 14 years
- Severe P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or positive PfHRP2 rapid diagnostic test (RDT).
- Pre-specified modified criteria for severe falciparum malaria
- Temperature >38°C on admission or fever during the preceding 48 hours.
- Less than 24 hours of antimalarial therapy
Key exclusion criteria (5 listed)
- Contraindication or known allergy to paracetamol
- Known chronic liver disease or tender hepatomegaly
- Known chronic kidney disease, history of renal replacement therapy or renal biopsy
- Participants who are already enrolled in another research trial involving an investigational product or have participated to the same study before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Acetyl-Para-Aminophenol (APAP), AcetaminophenParacetamol 15 mg/kg/dose IV 6 hourly for 72 hours | Drug | Arm 1 |
| Mechanical antipyresisMechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours. If a temperature >38.5°C persists despite mechanical antipyresis, or if deemed necessary by the treating clinician, then paracetamol can be administered according to local practice (paracetamol IV 15 mg/kg as needed). | Procedure or surgery | Arm 2 |
Primary outcome
Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome)
Time frame: during first 7 days of enrolment
Composite outcome of development of AKI (defined as creatinine ≥26.5 µmol/L or ≥1.5x baseline), or death at any timepoint
Acute kidney injury (AKI) progression or death among patients enrolled with AKI (Composite outcome)
Time frame: during first 7 days of enrolment
Composite outcome of worsening of AKI (defined as creatinine ≥2x baseline, or ≥3x baseline, or initiation of RRT or eGFR <35 ml/min/ 1.73 m2) or death at any timepoint.
21 secondary outcomes
Number of patients with serious adverse events
Time frame: AST/ALT/total bilirubin during the first 5 days from enrolment; mortality assessed Day 0 to 7.
Proportion of patients who develop Major Adverse Kidney Events (MAKE) composite
Time frame: 90 days
Fever clearance time
Time frame: 6-hourly temperature assessments during first 7 days from enrolment
Coma recovery
Time frame: 6-hourly GCS/BCS assessments during first 7 days from enrolment
Longitudinal change in renal function
Time frame: During the first 7 days from enrolment
Longitudinal change in markers of hemolysis
Time frame: during the first 3 days from enrolment
Longitudinal change of endothelial activation
Time frame: during the first 3 days from enrolment
Longitudinal change of immune activation
Time frame: during the first 3 days from enrolment
Longitudinal change of AKI biomarker
Time frame: during the first 3 days from enrolment
Parasite (parasites/ul) clearance
Time frame: 12-hourly parasitemia assessments during first 7 days from enrolment
Exploratory analysis with sex
Time frame: During first 7 days from enrolment
Pharmacokinetic properties
Time frame: during the first 24 hours from enrolment
Pharmacokinetic properties
Time frame: during the first 24 hours from enrolment
Pharmacokinetic properties
Time frame: during the first 24 hours from enrolment
Pharmacokinetic properties
Time frame: during the first 24 hours from enrolment
Pharmacokinetic properties
Time frame: during the first 24 hours from enrolment
Pharmacodynamic relationships
Time frame: during first 7 days from enrolment
Pharmacodynamic relationships
Time frame: during first 7 days from enrolment
Pharmacodynamic relationships
Time frame: during first 7 days from enrolment
Pharmacodynamic relationships
Time frame: during first 7 days from enrolment
Pharmacodynamic relationships
Time frame: during first 7 days from enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: Yes. Participant data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future. Datasets will be de-identified to ensure patient privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Plewes, Dr. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol and Mechanical antipyresis in people with Severe Malaria and Malaria,Falciparum, run by University of British Columbia at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Plewes, Dr. (+1-604-603-4033, katherine@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome) (time frame: during first 7 days of enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.