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NCT04682899

A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status unknown Phase 3 Last updated 24 December 2020
What this trial tests

Phase 3 trial testing procalcitonin-guided antibiotic therapy in Procalcitonin in 500 participants. Status unknown.

Timeline
1 February 2021
Primary endpoint
1 February 2022
1 April 2022

Quick facts

Lead sponsorCapital Medical University
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment500
Start date1 February 2021
Primary completion1 February 2022
Estimated completion1 April 2022

Drugs / interventions tested

Conditions studied

Sponsor

Capital Medical University

Who can join

40 and older, any sex, with Procalcitonin or Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Procalcitonin-guided initiation of antibiotics in AECOPD inpatients: study protocol for a multicenter randomised controlled trial.
    Huang L, Wang J, Gu X, Sheng W, et al · · 2021 · cited 4× · PMID 34353802 · DOI 10.1136/bmjopen-2021-049515

Verify or expand the search:

Other recruiting trials for Procalcitonin

Currently open trials in the same condition.

Other Capital Medical University trials

Trials by the same sponsor.

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