NCT06787885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

June 5, 2026

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

January 13, 2025

Last Update Submit

June 4, 2026

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 (2)

Patient with empyema

OTHER

Tavanic (levofloxacin )and dalacin (clindamycin)

Drug: Levofloxacin + cefipime

Empyema patient

OTHER

Tavanic (levofloxacin) and cefipime

Drug: Levofloxacin + clindamycin

Interventions

Levofloxacin + clindamycinDRUG

Group 1

Empyema patient
Levofloxacin + cefipimeDRUG

Group 2

Patient with empyema

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, Egypt

Location

MeSH Terms

Conditions

Empyema, Pleural

Interventions

LevofloxacinClindamycin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydrates

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

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

May 1, 2026

Study Completion

June 1, 2026

Last Updated

June 5, 2026

Record last verified: 2025-02

Locations

EG(1)