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

NCT06787885 | Recruiting

• 1 other identifier: M721
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Empyema, Pleural

Outcome Measures

Primary Outcomes (1)

• Evalutate different antibiotics

  To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy .

  2 weeks

Study Arms (3)

Patient with empyema

OTHER

Tavanic (levofloxacin )and dalacin (clindamycin)

Drug: Levofloxacin + cefipime

Empyema patient

OTHER

Tavanic (levofloxacin) and cefipime

Drug: Levofloxacin + clindamycin

patient has lung empyema

OTHER

Moxiflox (moxifloxacin) and meronem

Drug: Moxifloxacin + meronam

Interventions

Levofloxacin + clindamycin DRUG

Group 1

Empyema patient

Levofloxacin + cefipime DRUG

Group 2

Patient with empyema

Moxifloxacin + meronam DRUG

Group 3

patient has lung empyema

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hypersensitivity or Allergy to the selected antibiotic: Patients with a known history of hypersensitivity or allergic reactions to used antibiotics.
• Pregnancy and Lactation

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Empyema, Pleural

Interventions

Levofloxacin; Clindamycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Raghda Roshdy Hussein, Assistant professor

  Faculty of pharmacy Beni suef University

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Abdelrahman Ahmed Mohamed, Teaching assistant

  Faculty of pharmacy Fayoum University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelrahman Ahmed Mohamed, Teaching Assistant

CONTACT

+0201145154500; aa4496@fayoum.edu.eg

Marwa Kamal Tolba, Assistant professor

CONTACT

+201067789982; mka05@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 22, 2025
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

EG (1)