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.: PACTR202410744344899 Date of Registration: 30/10/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ceftazidime-Avibactam plus Aztreonam against MBL-producing K. pneumoniae
Official scientific title Ceftazidime/Avibactam plus Aztreonam Synergism as Successful Treatment for Metallo-β-lactamase-producing Multidrug-Resistant Klebsiella pneumoniae
Brief summary describing the background and objectives of the trial The spread of metallo-beta-lactamase-producing, multidrug-resistant Klebsiella pneumoniae (MBL-producing K. pneumoniae) is a serious public health concern that raises treatment costs, lengthens hospital stays, and increases the mortality rate. For doctors, treating such microorganisms poses significant challenges. The most effective strategy is probably ceftazidime/avibactam (CAZ/AVI) plus aztreonam (ATM). The study assessed the in vitro efficacy of CAZ/AVI in conjunction with ATM against clinical isolates of K. pneumoniae that produced MBL that were obtained from Suez Canal University Hospital patients.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied K. pneumoniae
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 01/06/2024
Actual Last follow-up date 20/06/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Klebsiella pneumoniae group Once 15 min. is required for sampling *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing 50
Control Group Healthy group Once 15 min. is required for sampling *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients of both sexes (male & female) and all age groups who showed signs and symptoms of infections and agreed to participate were included in this study. - Samples included were urine from catheterized and non-catheterized patients, respiratory specimens from intubated and non-intubated patients, Pus and wound swabs, pleural fluid, and blood. - Patients who received antibiotic treatment in the last 48 hours or refused to participate were excluded. 80 and over: 80+ Year,New born: 0 Day-1 Month 13 Day(s) 80 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 07/11/2022 Research Ethics Committee of the Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Ismaellia Ismaellia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Isolation and identification of K. pneumoniae throughout the intervention
Secondary Outcome evaluated the in vitro activity of CAZ/AVI in combination with ATM against MBL-producing K. pneumoniae clinical isolates throughout the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals Ismailia Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Ahmed Othman Faculty of Medicine, Suez University, Suez, Egypt Suez 43511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospitals Ismailia Ismailia 41522 Egypt University
Secondary Sponsor Suez University Faculty of Medicine Suez Suez 43511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Othman Amira.Othman@med.suezuni.edu.eg 00201003258097 Faculty of medicine, Suez University, Suez, Egypt
City Postal code Country Position/Affiliation
Suez 43511 Egypt Professor
Role Name Email Phone Street address
Public Enquiries Hasnaa Azab hasnaa_azab@med.suez.edu.eg 00201003258097 Faculty of medicine, Suez Canal University, Ismaellia, Egypt
City Postal code Country Position/Affiliation
Ismaellia 41522 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Sally Khattab sally.maged@med.suez.edu.eg 00201003258097 Faculty of medicine, Suez Canal University, Ismaellia, Egypt
City Postal code Country Position/Affiliation
Ismaellia 41522 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data Will be available, All of the individual participant data collected during the trial, after de- identification Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Oped
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 22/10/2024 Each criteria on a new line -Patients of both sexes (male & female) and all age groups who showed signs and symptoms of infections and agreed to participate were included in this study. Samples included were urine from catheterized and non-catheterized patients, respiratory specimens from intubated and non-intubated patients, Pus and wound swabs, pleural fluid, and blood. -Patients of both sexes (male & female) and all age groups who showed signs and symptoms of infections and agreed to participate were included in this study. - Samples included were urine from catheterized and non-catheterized patients, respiratory specimens from intubated and non-intubated patients, Pus and wound swabs, pleural fluid, and blood.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 22/10/2024 Each criteria on a new line -Patients who received antibiotic treatment in the last 48 hours or refused to participate were excluded. - Patients who received antibiotic treatment in the last 48 hours or refused to participate were excluded.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/10/2024 15 min. is required for sampling Experimental Group, Patients admitted to Suez Canal University Hospitals in Ismailia, Once, 15 min., *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Experimental Group, Patients admitted to Suez Canal University Hospitals in Ismailia, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/10/2024 15 min. is required for sampling Experimental Group, Patients admitted to Suez Canal University Hospitals in Ismailia, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Experimental Group, Klebsiella pneumoniae group, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/10/2024 15 min. is required for sampling Control Group, Workers, Once, 15 minutes, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Uncontrolled Control Group, Workers, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 24/10/2024 15 min. is required for sampling Control Group, Workers, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Uncontrolled Control Group, Healthy group, Once, 15 min. is required for sampling, *Sampling (Blood, Urine , Sputum, Endotracheal aspirate , Pus and wound exudate , Pleural fluid ) *Study procedure: 1. Full history taking, and thorough physical examination 2.Samples collection and preservation (Blood, Urine , Sputum , Endotracheal aspirate ,Pus and wound exudate , Pleural fluid ). 3. Bacterial Isolation, Identification and Molecular confirmation. 4. Molecular detection of EMetallo-β-lactamase genes by conventional PCR 5.Antibiotic sensitivity testing, 50, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 22/10/2024 Identified as 13 days 13 Select Min 13 Day(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 22/10/2024 Identified as 80 years 80 Select Max 80 Year(s)