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NCT05955612: PROCALBAN
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults
Phase 3 trial testing Procalcitonin measurement in Sepsis in 532 participants. Completed in 30 July 2024.
20 June 2024
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 532 |
| Start date | 26 July 2023 |
| Primary completion | 20 June 2024 |
| Estimated completion | 30 July 2024 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Procalcitonin measurement
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
University of Oxford
Who can join
Adults 16 to 65, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Trial design: Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with sepsis. Trial settings Trial site is Chattogram Medical College Hospital (CMCH), Bangladesh. CMCH is tertiary care hospital with undergraduate and postgraduate teaching facilities. This tertiary hospital receives referrals from urban and rural areas of southern Bangladesh and has basic facilities for intensive care and haemodialysis. Trial Participants: Male or female hospitalised patients, 16-65 years of age, with confirmed or suspected sepsis Patients (Total 532) will be 1:1 randomised to either: * Intervention arm: daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics (Intervention arm: 266), or * Control arm: standard of practice to guide de-escalation of antibiotics without procalcitonin assessments (Control arm: 266). Patients will be followed-up until ICU discharge and/or hospital discharge with an additional follow-up at 28 days after discharge. Funder: Wellcome Trust of Great Britain Grant reference number from Wellcome Trust: 220211/A/20/Z
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 NCT05955612
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Procalcitonin measurement
Trials testing the same drug.
- NCT03333304 — A Clinical Trial of Procalcitonin-guided Antimicrobial Therapy in Sepsis · NA · completed
- NCT00987818 — Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU · NA · withdrawn
Other recruiting trials for Sepsis
Currently open trials in the same condition.
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- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other University of Oxford trials
Trials by the same sponsor.
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- NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
- NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
- NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
- NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting
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 NCT05955612 (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 University of Oxford
- Last refreshed: 26 November 2024
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/NCT05955612.
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