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.: PACTR202404502445612 Date of Approval: 22/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study of the efficacy of Ceftaroline in the management of pediatric severe sepsis and septic shock
Official scientific title Study of the efficacy of Ceftaroline in the management of pediatric severe sepsis and septic shock
Brief summary describing the background and objectives of the trial Sepsis is a leading cause of morbidity, mortality, and healthcare utilization for children worldwide. Globally, an estimated 22 cases of childhood sepsis per 100,000 person-years, translating into 1.2 million cases of childhood sepsis per year. More than 4% of all hospitalized patients less than 18 years and around 8% of patients admitted to PICUs in high-income countries have sepsis.Mortality for children with sepsis ranges from 4% to as high as 50%, depending on illness severity, risk factors, and geographic location. The majority of children who die of sepsis suffer from refractory shock and/or multiple organ dysfunction syndrome, with many deaths occurring within the initial 48–72 h of treatment.One of the most promising novel antimicrobials, initially approved in 2010, is ceftaroline fosamil, a fifth-generation cephalosporin which proved a broad-spectrum activity against gram-positive (including methicillin susceptible Staphylococcus aureus and MRSA) and – gram negative bacteria. This study is designed to assess the efficacy and effectiveness of ceftaroline in empirical management of children with severe sepsis & septic shock among patients admitted to Pediatric intensive care unit of Alexandria university.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2022
Actual trial start date 01/07/2023
Anticipated date of last follow up 30/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ceftaroline Ceftaroline dose 8-12mg/kg/dose Aminoglycoside (amikin 15mg/kg/day –gentamycin 5-7.5 mg/kg/day Starting empirically when severe sepsis diagnosed, every 8 hours till results of blood or CSF, urine, pleural fluid cultures Given as empirical treatment Starting empirically when severe sepsis diagnosed, every 8 hours till results of blood or CSF, urine, pleural fluid cultures 23
Control Group Third generation Cephalosporin Ceftriaxone 100mg/kg/day Aminoglycoside (amikin 15mg/kg/day –gentamycin 5-7.5 mg/kg/day ) Vancomycin 15-20mg/kg/dose Starting empirically when severe sepsis diagnosed, every 8 hours till results of blood or CSF, urine, pleural fluid cultures Given as empirical treatment Starting empirically when severe sepsis diagnosed, every 8 hours till results of blood or CSF, urine, pleural fluid cultures 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Severe sepsis or septic shock as defined by The Surviving Sepsis Campaign (SSC) guidelines 2020. - Severe immunodeficiency patients (congenital or acquired). - Malignancies and patients receiving chemotherapy. - Hypersensitivity to any active substances of the drug. - Cases that received Ceftaroline prior to admission Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 2 Month(s) 12 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 20/10/2022 The ethics committee of the Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, E Messalah Alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome C-reactive protein CRP blood level Daily until total improvement
Primary Outcome Negative Blood CSF Urine Pleural cultures results At the time of clinical improvement
Secondary Outcome Length of Pediatric Intensive Care Unit stay Till discharge form Pediatric Intensive Care Unit
Secondary Outcome Number of Days of Therapy till end of therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric intensive care unit El Shatby hospital Alexandria University Portsaid street, El Shatby Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Bassant Mohamed Ahmed Mohamed Abdelkader 4 Elsharka el Arabi el Seouf Shamaa Alexandria 21533 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric department Faculty of Medicine Alexandria University Portsaid street, El Shatby Alexandria 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Bassant Mohamed Ahmed Mohamed Abdelkader 4 Elsharka el arabi el seouf shamaa Alexandria 21533 Egypt
Ahmed Ahmed El nawawy Portsaid street, El Shatby Alexandria 21563 Egypt
Manal Abdel Malik Antonios Portsaid street, El Shatby Alexandria 21563 Egypt
Hadir Mohamed Hassouna Portsaid street, El Shatby Alexandria 21563 Egypt
Marwa Ahmed Meheissen Portsaid street, El Shatby Alexandria 21563 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Nawawy dr_anawawy@yahoo.com 002034831061 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Lecturer of Pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Manal Antonios malakmanal@yahoo.com 00201229733422 El Shatby hospital, Porsaid street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt Professor of pediatrics Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Bassant Abdelkader BassantAbdelkader@gmail.com 0021286900933 4 Elsharka el arabi el seouf shamaa
City Postal code Country Position/Affiliation
Alexandria 21533 Egypt Lecturer of Pediatrics Faculty of Medicine University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: Immediately following publication with no end date. For anyone who wishes to access the data For any type (purpose) of analyses Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
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