Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003255157 Date of Approval: 27/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Aggressive Antipyretics for Fever Reduction in CNS Malaria
Official scientific title Aggressive Antipyrectics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects
Brief summary describing the background and objectives of the trial The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 27/04/2018
Actual trial start date 02/07/2018
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 284
Actual target sample size (number of participants) 256
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ClinicalTrials.gov ID: NCT03399318
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program sealed envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aggressive Antipyretics 30mg/kg load then 15 mg/kg Q6 hours 72 hours Acetaminophen 128
Experimental Group Aggressive Antipyretics 10mg/kg Q6 hours 72 hours Ibuprofen 128
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Evidence of P. falciparum malaria infection by peripheral blood smear or rapid diagnostic test. 2. CNS symptoms associated with malaria. Cerebral malaria: Impaired consciousness with a Blantyre Coma Score (BCS)(73)less than or equal to 2 in children under 5 yrs or a Glasgow Coma Score (GCS)less than or equal to 10 in children greater than or equal to 5 yrs OR CNS MALARIA: Complicated seizure(s), meaning prolonged (>15 minutes), focal or multiple; or impaired consciousness or other evidence of impaired consciousness (confusion, delirium) without frank coma (BCS>2,GCS=11-14). 1. Circulatory failure (cold extremities, capillary refill > 3 seconds, sunken eyes, decreased skin turgor). 2. Vomiting in the past 2 hrs. 3. Serum Cr> 1.2 mg/dL. 4. A hx of liver disease. 5. Jaundice or a total bilirubin of >3.0mg/dL. 6. A hx of gastric ulcers or gastrointestinal bleeding. 7. A hx of thrombocytopenia or other primary hematologic disorder. 8. Petechiae or other clinical indications of bleeding abnormalities. 9. A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medication. 10. Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications. 2 Year(s) 11 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/12/2017 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi Road Blantyre 3 0000 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/08/2018 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Lusaka, Zambia Lusaka 00000 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean maximum temperature (TMAX). Continuous temp monitors not MRI compatible. If TMAX is clinical temp obtained when continuous monitoring data not available, clinical TMAX will be used as primary outcome TMAX defined as highest temperature during study duration, 72 hours, in degrees Celsius recorded by continuous temp monitor. Continuous temp monitors not MRI compatible.
Secondary Outcome Seizures Seizures detected clinically or on daily EEG during the study duration (72 hours)
Secondary Outcome Parasite burden based upon HRP2 levels and quantitative blood film Q6 hourly until aparasitemic on thick blood smear, 72 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Queen Elizabeth Central Hospital Chipitala Avenue, Chichiri Blantyre 3 Malawi
University Teaching Hospital's Lusaka Childrens Hospital Nationalist Road Lusaka Zambia
Chipata Central Hospital PO Box 510119 Chipata Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
NIH 9000 Rockville Pike Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Rochester 601 Elmwood Avenue Rochester 14642 United States of America University
COLLABORATORS
Name Street address City Postal code Country
NINDS P. O. Box 5801 Bethesda 20824 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gretchen Birbeck gretchen_birbeck@urmc.rochester.edu +265995008069 Chipitala Avenue, Chichiri
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Professor
Role Name Email Phone Street address
Scientific Enquiries Karl Seydel seydel@msu.edu +265999452989 Chipitala Avenue, Chichiri
City Postal code Country Position/Affiliation
Blantyre 3 Malawi Co-Principal Investigator
Role Name Email Phone Street address
Public Enquiries Moses Chilombe moses.chilombe.fever@gmail.com +265999368845 Lusaka
City Postal code Country Position/Affiliation
Lusaka 0000 Zambia Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information