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.: PACTR202401622249032 Date of Approval: 16/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of the safety and efficacy of levofloxacin and ciprofloxacin in the treatment of community-acquired, bacterial urinary tract infection among patients with chronic kidney disease
Official scientific title Comparative study of the safety and efficacy of levofloxacin and ciprofloxacin in the treatment of community-acquired, bacterial urinary tract infection among patients with chronic kidney disease
Brief summary describing the background and objectives of the trial Infectious complications in individuals with CKD constitute a significant source of morbidity and mortality. UTI, is the commonest precipitant of acute exacerbation of CKD and its progression9. Consequent upon the vital role of kidneys in the elimination of xenobiotics, treatment of UTI requires selection of appropriate antibiotics in order to prevent further kidney injury. The Enterobacteriaceae, particularly E coli, are the most common pathogen in community-acquired infections. Acceptable regimens include fluoroquinolones, cephalosporins, penicillins, extended-spectrum penicillins, carbapenems, and aminoglycosides. Thus, there is need to compare the efficacy and safety of ciprofloxacin to the standard of care, levofloxacin as ciprofloxacin is relatively cheaper hence conferring some economic and perhaps, adherence advantage among the resource-challenged CKD patients. General Objective The broad objective is to compare the safety and efficacy of ciprofloxacin with that of levofloxacin in patients with CKD and UTI with a view of establishing non-inferiority of ciprofloxacin.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SELC
Disease(s) or condition(s) being studied Infections and Infestations,Kidney Disease
Sub-Disease(s) or condition(s) being studied Urinary tract infection, Chronic kidney disease
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/10/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 87
Recruitment status Completed
Publication URL 0
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ciprofloxacin 400 mg IV twice daily or 500 mg orally twice daily for 10 days 10 days Ciprofloxacin is a 2nd generation fluoroquinolone. Ciprofloxacin attains therapeutic concentrations in most tissues and body fluids. It is effective in the treatment of a wide variety of infections, including complicated UTI, sexually transmitted diseases skin and bone infections, gastrointestinal infections caused by multi-resistant organisms, lower respiratory tract infections, intra-abdominal infections, and malignant external Otitis. Ciprofloxacin is available for oral and parenteral administrations. 43
Control Group Levofloxacin 250 mg IV or Oral daily for 10 days 10 days Levofloxacin, a fluoroquinolone, is the optical S-(-) isomer of ofloxacin. It is a third generation fluoroquinolone with broad spectrum activity. 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18years and above. 2. Known CKD patients 3. Symptoms compatible with a diagnosis of UTI plus positive dipstick test for pyuria 4. Informed consent to participate in the study. 1. Patients with any rapidly progressive or terminal disease 2. Individuals with prior renal transplantation. 3. Co-existence of other infections in addition to urinary tract infection 4. Exposure to any antimicrobial prior to presentation 5. Known previous reaction to quinolones. 6. Hospital acquired UTI 7. Catheter associated UTI 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 28/08/2020 University of Ibadan University College Hospital Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Biode Building, Room 210, 2nd floor, Institute for Advanced Medical Research and Training IMRAT, College of Medicine, University of Ibadan Ibadan 200212 Nigeria
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 02/05/2023 UI UCH Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Biode Building, Room 210, 2nd floor, Institute for Advanced Medical Research and Training IMRAT, College of Medicine, University of Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Efficacy as determined by clinical resolution, clearance of signs and symptoms 2. Tolerability of drug as determined by Treatment Emergent Symptoms and Signs (TESS) days 3, 7, 28 and 90
Secondary Outcome 1. Duration of hospital stay and/or hospitalization and/or re-hospitalization 2. Rate of re-occurrence of UTI and/or any bacterial infections during the subsequent 3 months of follow up. 3. All-cause mortality among participants days 3, 7, 28 and 90
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road, Oritamefa Ibadan Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dhikrullah Adebayo Ground floor, Akinkugbe Clinical Building, Department of Clinical Pharmacology, University College Hospital Ibadan. Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dhikrullah Adebayo Ground floor, Akinkugbe Clinical Building, Department of Clinical Pharmacology, University College Hospital Ibadan. Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dhikrullah Adebayo adeyemidhik@gmail.com +2348038634007 Ground floor, Akinkugbe Clinical Building, Department of Clinical Pharmacology, University College Hospital, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Adebayo Dhikrullah adeyemidhik@gmail.com +2348038634007 Ground floor, Akinkugbe Clinical Building, Department of Clinical Pharmacology, University College Hospital, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Fatai Fehintola fentolamine@yahoo.com +2348064251270 Ground floor, Akinkugbe Clinical Building, Department of Clinical Pharmacology, University College Hospital, Ibadan
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from this study will be available to interested researchers 6 months after publication and ends 18 months after. Proposal should be sent to adeyemidhik@gmail.com Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted 6 months after article publication and availability ends after 24 months of article publication Qualified researchers can have access to data after approval of the research proposal. There will be signing of data access agreement. Information can be forwarded to adeyemidhik@gmail.com
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