NCT06915688

Brief Summary

This study will include patients with chronic obstructive pulmonary disease (COPD) who present with an acute exacerbation. Participants will be randomly assigned to receive either doxycycline or levofloxacin for 5 days. The aim is to compare how effective each antibiotic is in improving symptoms after 2 days of treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 19, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Clinical Cure Rate

    1. A decrease in the respiratory rate by 20% from the baseline measurement. 2. Restoration of Oxygen saturation levels to within the range of 88-92% on room air. 3. CRP\<10ng/ml 4. decrease in sputum quantity 5. reduction in body temperature below 99•F 6. TLC \<11,000

    7 days

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Doxycycline will be given to this group

Drug: Doxycycline

Arm 2

ACTIVE COMPARATOR

Levofloxacin in copd patients

Drug: Levofloxacin

Interventions

Doxycycline will be given to COPD group 1

Arm 1

Levofloxacin given to copd patients

Arm 2

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed cases of COPD Exacerbation of COPD Able to provide Written consent No anti biotic taken with in past 4 weeks

You may not qualify if:

  • hypersensitivity to any drugs Pneumonia evidence on xray/ hrct chest Any other pulmonary condition e.g asthma Pregnancy/breast feeding Taking treatment for other active infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DoxycyclineLevofloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Amina Aslam, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
AAslam

Study Record Dates

First Submitted

March 19, 2025

First Posted

April 8, 2025

Study Start

April 15, 2025

Primary Completion

July 28, 2025

Study Completion

July 31, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Locations