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.: PACTR202308507206446 Date of Approval: 03/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The use of levofloxacin versus amoxycillin/clavulanic acid combined with azithromycin in treatment of community acquired pneumonia
Official scientific title Levofloxacin versus amoxycillin/clavulanic acid combined with azithromycin in treatment of community acquired pneumonia
Brief summary describing the background and objectives of the trial Background: Community acquired pneumonia (CAP) is an important cause of mortality and morbidity worldwide. Early initiation of antibiotics is highly recommended. In most CAP cases, multiple drug options are increasingly becoming available, but there is often a lack of evidence that allows for direct comparison of the efficacy of one drug versus another. The purpose of this study is to investigate the effectiveness of antibiotics so as to rationalize outpatient treatment of community acquired pneumonia among patients with previous antibiotic exposure. Aim: The main objective is to compare treatment outcomes using oral levofloxacin alone and combined azithromycin and amoxicillin/Clavulanic acid in outpatient treatment of Community acquired pneumonia.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2022
Actual trial start date 30/11/2022
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date 30/12/2022
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants) 66
Recruitment status Closed to recruitment,follow-up continuing
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group NA NA NA NA 0 Active-Treatment of Control Group
Experimental Group Levofloxacin alone 500mg twice daily 5 days The patients who were diagnosed with community acquired pneumonia were given the drug for 5 days 29
Experimental Group AmoxycillinClavulanic and azithromycin 625mg twice daily and azithromycin 500mg once daily 3-5 days patients diagnosed with community acquired pneumonia were treated 37
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosed with CAP in outpatient Gives verbal consent Allergic to levofloxacin allergic to amoxycillin allergic to azithromycin 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(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 07/12/2021 Baraton University of East Africa Research committee
Ethics Committee Address
Street address City Postal code Country
Eldoret Eldoret 30100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduced body temperature, normal respiratory rate, normalized white blood cell count 3 and 5 days
Secondary Outcome Reduced cough, absent crackles 5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Monica Hospital Kisumu Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Salary Kisumu Kisumu 40100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Vincent Musungu Kisumu Kisumu 40100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Daniel Onguru Jaramogi Odinga Oginga University Kisumu 40100 Kenya
Dr Patrick Onyango Maseno University Kisumu 40100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vincent Musungu vinn.musungu@gmail.com +254728556330 Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Jaramogi Odinga Oginga University of Science and Technology
Role Name Email Phone Street address
Public Enquiries Vincent Musungu vinn.musungu@gmail.com +254728556330 Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Jaramogi Odinga Oginga University of science and technology
Role Name Email Phone Street address
Scientific Enquiries Vincent Musungu vinn.musungu@gmail.com +254728556330 Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Jaramogi Oginga Odinga University of science and technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices Informed Consent Form,Study Protocol 6mo Access to any information in this study can be obtained upon request to the principal investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/07/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/07/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information