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NCT02446782: APT
A Study to Evaluate the Efficacy and Safety of a Single Dose of an Injectable Antibiotic for the Prophylaxis of Surgical Site and Pleural Space Infection After Medical Thoracoscopy
Phase 4 trial testing Cefazolin in Pleural Effusion in 100 participants. Completed in 1 June 2016.
1 April 2016
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 1 January 2015 |
| Primary completion | 1 April 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across India |
Drugs / interventions tested
- Cefazolin (CEFAZOLIN) — full drug profile →
- saline
Conditions studied
- Pleural Effusion — all drugs for Pleural Effusion →
- Pleurisy — all drugs for Pleurisy →
- Empyema — all drugs for Empyema →
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Who can join
Adults 12 to 80, any sex, with Pleural Effusion or Pleurisy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Efficacy as assessed by occurrence of wound infection or pleural space infection
Time frame: 2 months
(a) Occurrence of wound infection as indicated by development of a purulent discharge from the surgical site or (b) pleural space infection as indicated by development of purulence, fall in sugar levels or gram's stain or culture positivity in the pleural fluid drained by the chest tube on the side of the procedure.
Sponsor's own description
This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02446782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cefazolin
Trials testing the same drug.
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- NCT07478874 — Prophylaxis Against Surgical Site Infections Using Local as Well as Systemic Antibiotic · NA · completed
- NCT07111702 — Prophylactic Antibiotics in Groin Hernioplasty · NA · completed
- NCT05647993 — Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean De · NA · completed
- NCT05137119 — Staphylococcus Aureus Network Adaptive Platform Trial · Phase 4 · recruiting
Other recruiting trials for Pleural Effusion
Currently open trials in the same condition.
- NCT07248774 — Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion · NA · recruiting
- NCT07012759 — Pleural Effusion Biomarkers in Lung Adenocarcinoma Patients · recruiting
- NCT06958848 — 16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy · NA · recruiting
- NCT06892691 — Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions · NA · recruiting
- NCT06314620 — Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency · NA · recruiting
Other Post Graduate Institute of Medical Education and Research, Chandigarh trials
Trials by the same sponsor.
- NCT07322237 — DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis · Phase 4 · recruiting
- NCT07436988 — Affordable Made-in-India Microspheres for Liver Cancer Therapy · Phase 1 · not yet recruiting
- NCT07286643 — Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis · NA · recruiting
- NCT07280390 — Microplastics, Cirrhosis and Portal Hypertension · not yet recruiting
- NCT07182877 — Comparison of Dwell Time of Open Versus Closed Type Peripheral Intravenous Cannula · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02446782 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 16 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02446782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing