The use of procalcitonin in patients of acute exacerbation of chronic obstructive disease in which people within intervention group will not receive antibiotic and will be seen for progression to severe disease, time to clinical resolution and days of antibiotic exposure in control group.

Role of procalcitonin guided antibiotic initiation on the treatment outcome in acute exacerbation of Chronic obstructive pulmonary disease - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068078

Enrollment

Registered

2024-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: Conventional treatment without antibiotics: Patients will be receiving conventional treatment which includes nebulization with inhaled short acting beta agonist i.e. Salbutamol every 6

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patient should be a diagnosed case of COPD. 2) Patient should have moderate acute exacerbation of COPD according to latest GOLD guidelines 2023. 3) On presentation procalcitonin levels should be less than 0.1 mcg per liter.

Exclusion criteria

Exclusion criteria: 1) Mild and severe cases of acute exacerbation of COPD. 2) Those with lobar consolidation patch on chest X ray. 3) Received antibiotic for more than 48 hours at time of enrollment. 4) Immunocompromised patients, i.e. HIV infection, neutropenic patients (1000 Ã? 109 per L), stem cell transplant recipients, patients of leukemia/lymphoma. 5) Co-existence of inflammatory conditions which can lead to increase in serum PCT levels

Design outcomes

Primary

Measure	Time frame
Compare incidence of progression to Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease in both the groups which involves new onset or worsening hypercapnia and acidosis on arterial blood gas examination.Timepoint: Day 3,7 and 14	—

Secondary

Measure	Time frame
To compare the time to clinical resolution between intervention group and control group as defined by ROME criteria for mild acute exacerbation of chronic obstructive pulmonary disease by visual analog scale, respiratory rate, heart rate, oxygen saturation and arterial blood gas parametersTimepoint: day 3,7 and 14;To estimate the duration of antibiotic therapy (patient days) in the intervention group and the control group receiving standard careTimepoint: Day 3,7 and 14	—

Measure

Time frame

To compare the time to clinical resolution between intervention group and control group as defined by ROME criteria for mild acute exacerbation of chronic obstructive pulmonary disease by visual analog scale, respiratory rate, heart rate, oxygen saturation and arterial blood gas parametersTimepoint: day 3,7 and 14;To estimate the duration of antibiotic therapy (patient days) in the intervention group and the control group receiving standard careTimepoint: Day 3,7 and 14

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Countries

India

Contacts

Public ContactDr Pritam Singh

Government Medical College and Hospital, sector 32, Chandigarh

pritam_doc@yahoo.com9646121560

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026