Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema

June 4, 2026 updated by: Abdelrahman Ahmed Mohamed, Fayoum University
To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy and evaluate the clinical outcomes regarding safety, efficacy, and pharmacodynamics parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egypt
        • Fayoum University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Confirmed Diagnosis of Empyema: Patients with a clinical and radiological diagnosis of

Exclusion Criteria:

1 - Hypersensitivity or Allergy to the selected antibiotic: Patients with a known history of hypersensitivity or allergic reactions to used antibiotics.

2- Pregnancy and Lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient with empyema
Tavanic (levofloxacin )and dalacin (clindamycin)
Drug: Levofloxacin + cefipime
Group 2
Other: Empyema patient
Tavanic (levofloxacin) and cefipime
Drug: Levofloxacin + clindamycin
Group 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evalutate different antibiotics
Time Frame: 2 weeks
To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy .
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

  • Study Chair: Raghda Roshdy Hussein, Assistant professor, Faculty of pharmacy Beni suef University
  • Study Director: Marwa Kamal Tolba, Assistant professor, Faculty of pharmacy Fayoum University
  • Study Director: Yassmin Mohamed Medany, Lecturer, Faculty of pharmacy Benisuef University
  • Study Director: Mona Ibrahim Ahmed, Assistant professor, Faculty of Medicine Fayoum University
  • Principal Investigator: Abdelrahman Ahmed Mohamed, Teaching assistant, Faculty of pharmacy Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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