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.: PACTR202207829542810 Date of Approval: 18/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Bacterial and antibiotic sensitivity pattern in secondary peritonitis at University College Hospital, Ibadan
Official scientific title Bacterial and antibiotic sensitivity pattern in secondary peritonitis at University College Hospital, Ibadan
Brief summary describing the background and objectives of the trial Background: Peritonitis is inflammation of the peritoneum usually as a result of a localised or generalised infection. Secondary peritonitis which is the more common type follows a pathologic process in a visceral organ. Escherichia coli and Bacteroides fragilis are the commonest organisms isolated from peritoneal fluid of patients with secondary peritonitis. The role of peritoneal cultures and use of antibiotics effective against culture results remains controversial. Some earlier studies revealed that culture result data rarely contributed in a useful way to the patient’s postoperative outcome. Other studies show an improvement in patients’ outcome with antibiotics use according to culture and sensitivity. Objective: This study was conducted to determine the bacterial and antibiotic sensitivity pattern in patients with secondary peritonitis at University College Hospital Ibadan. It was aimed to determine the correlation between peritoneal cultures and outcome of patients with secondary peritonitis, and compare the use of empirical antibiotics and culture-sensitive antibiotics with outcome of patients with secondary peritonitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/06/2018
Actual trial start date 03/06/2018
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Culture sensitive antibiotics 7 days Five millilitres of peritoneal fluid was sampled intra-operatively and microscopy, culture and sensitivity testing for aerobic and anaerobic isolates were performed on these samples. The experimental group had empirical antibiotics (Ceftriaxone + Metronidazole) for the first two days, and antibiotics according to peritoneal fluid culture and sensitivity report for the remaining five days. 30
Control Group Empirical antibiotics 7 days Five millilitres of peritoneal fluid was sampled intra-operatively and microscopy, culture and sensitivity testing for aerobic and anaerobic isolates were performed on these samples. This group had empirical antibiotics (Ceftriaxone + Metronidazole) for seven days. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study comprised all consenting patients aged 16 years and above with secondary peritonitis presenting through the Emergency Department of University College Hospital, Ibadan from June 2019 to December 2020. Individuals with secondary peritonitis who were not operated upon within 24 hours of admission. The rationale behind this is prolonged antibiotic therapy prior to surgical intervention may affect yield of culture of peritoneal fluid sampled during laparotomy Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 66 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 16/02/2018 Institute for Advanced Medical Research and Training
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth road, Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Length of hospital stay and mortality. During intervention
Secondary Outcome Return of bowel function and presence of post-operative pyrexia, surgical site infection, wound dehiscence, abscesses During intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth road Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adedoyin B. Ojo Department of Surgery, University College Hospital Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adedoyin Ojo Department of Surgery, University College Hospital Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adedoyin Ojo ojo.adedoyin@yahoo.com +2348035997708 Queen Elizabeth road
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant General Surgeon
Role Name Email Phone Street address
Public Enquiries Adedoyin Ojo ojo.adedoyin@yahoo.com +2348035997708 Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant General Surgeon
Role Name Email Phone Street address
Scientific Enquiries Adedoyin Ojo ojo.adedoyin@yahoo.com +2348035997708 Queen Elizabeth road
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant General Surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results and the study protocol Informed Consent Form,Study Protocol The period of availability of IPD sharing is 5 years Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/12/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/07/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information