Empyema, PleuralNCT06787885
Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema
A study testing Levofloxacin + clindamycin and Levofloxacin + cefipime in people with Empyema, Pleural, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Empyema, Pleural
- What is being tested?
- Levofloxacin + clindamycin and Levofloxacin + cefipime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed Diagnosis of Empyema: Patients with a clinical and radiological diagnosis of
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Levofloxacin + clindamycin, Levofloxacin + cefipime
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin + clindamycinDrug
Group 1
Levofloxacin + cefipimeDrug
Group 2
| Study group | Role | What they receive |
|---|---|---|
| Patient with empyema | Other | Tavanic (levofloxacin )and dalacin (clindamycin) Receives: Drug: Levofloxacin + cefipime |
| Empyema patient | Other | Tavanic (levofloxacin) and cefipime Receives: Drug: Levofloxacin + clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evalutate different antibiotics
To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy .
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 May 2024
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ahmed Mohamed, Fayoum University
- Investigators
- Raghda Roshdy Hussein, Assistant professor, Study chair, Faculty of pharmacy Beni suef UniversityMarwa Kamal Tolba, Assistant professor, Study director, Faculty of pharmacy Fayoum UniversityYassmin Mohamed Medany, Lecturer, Study director, Faculty of pharmacy Benisuef UniversityMona Ibrahim Ahmed, Assistant professor, Study director, Faculty of Medicine Fayoum UniversityAbdelrahman Ahmed Mohamed, Teaching assistant, Principal investigator, Faculty of pharmacy Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787885
- Sponsor's protocol ID
- M721
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema
- ClinicalTrials.gov ID
- NCT06787885
- Acronym / sponsor ID
- M721
- Conditions
- Empyema, Pleural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with empyema | Other | Drug: Levofloxacin + cefipimeTavanic (levofloxacin )and dalacin (clindamycin) |
| Empyema patient | Other | Drug: Levofloxacin + clindamycinTavanic (levofloxacin) and cefipime |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed Diagnosis of Empyema: Patients with a clinical and radiological diagnosis of
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin + clindamycinGroup 1 | Drug | Empyema patient |
| Levofloxacin + cefipimeGroup 2 | Drug | Patient with empyema |
Primary outcome
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghda Roshdy Hussein, Assistant professor study chair
Faculty of pharmacy Beni suef University
Marwa Kamal Tolba, Assistant professor study director
Faculty of pharmacy Fayoum University
Yassmin Mohamed Medany, Lecturer study director
Faculty of pharmacy Benisuef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin + clindamycin and Levofloxacin + cefipime in people with Empyema, Pleural, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalutate different antibiotics (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.