Impact of Pharmacist Led Multidisciplinary Deprescribing Strategy in Patients With Respiratory Tract Infections

NCT07849491 | Enrolling By Invitation DMC

• 1 other identifier: F-5-2/2024(ERRC)/PIMS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, open-label, randomized controlled trial will evaluate the impact of a pharmacist-led multidisciplinary deprescribing strategy on azithromycin use in clinically stable adults aged 18-65 years with respiratory tract infections. A total of 200 participants will be randomly allocated in a 1:1 ratio to an intervention group or control group. The intervention group will receive pharmacist-led medication review and reassessment of azithromycin therapy, including dose optimization or discontinuation when appropriate, in collaboration with physicians. The control group will receive usual physician-directed care without a structured deprescribing intervention. Participants will be assessed at 48-72 hours and at the end of therapy. The primary outcomes will include appropriate azithromycin use, clinical cure, and treatment failure. Secondary outcomes will include adverse drug reactions, medication adherence, symptomatic improvement, and quality of life.

Conditions

Respiratory Tract Diseases

Keywords

Azithromycin; Respiratory Tract Infections; Antibiotic Deprescribing

Outcome Measures

Primary Outcomes (3)

• Optimal Azithromycin Use

  Proportion of participants receiving appropriate azithromycin therapy based on indication, dose, duration, and adherence to applicable clinical guidelines and the study protocol.

  Baseline through end of therapy (Day 5-7)

• Clinical Cure Rate

  Proportion of participants with resolution or substantial improvement of respiratory tract infection symptoms at the end of therapy.

  Day 5-7

• Treatment Failure Rate

  Proportion of participants with persistent or worsening symptoms, positive culture where applicable, relapse, or death attributable to the respiratory tract infection.

  Day 5-7

Secondary Outcomes (3)

• Quality of Life of Participants a who are a part of this study

  Baseline through 48-72 hours till end of the therapy (5-7 days)

• Medication Adherence

  Baseline through 48-72 hours till end of the therapy (5-7 days)

• Symptomatic Resolution

  Baseline through 48-72 hours till end of the therapy (5-7 days)

Study Arms (2)

Control Arm

NO INTERVENTION

The control arm will receive usual physician-directed care for azithromycin without any structured pharmacist-led deprescribing intervention. Treatment decisions, including continuation, modification, or discontinuation of azithromycin, will remain at the discretion of the treating physician/GP according to routine clinical practice.

Pharmacist-Led Azithromycin Deprescribing Intervention

EXPERIMENTAL

The intervention arm will receive a pharmacist-led multidisciplinary deprescribing intervention involving assessment of azithromycin use and discussion of recommendations with the treating physician/GP. The pharmacist may recommend continuation, optimization, or discontinuation of azithromycin, while the final treatment decision remains with the physician/GP.

Drug: Pharmacist-Led Azithromycin Deprescribing Intervention

Interventions

Pharmacist-Led Azithromycin Deprescribing Intervention DRUG

A structured pharmacist-led intervention in which the pharmacist assesses the indication, dose, frequency, duration, and concomitant medications related to azithromycin therapy and discusses recommendations with the treating physician/GP. Recommendations may include continuation, optimization, or discontinuation of azithromycin, with the final treatment decision made by the physician/GP. Reassessment is conducted at 48-72 hours and at the end of therapy (Day 5-7).

Pharmacist-Led Azithromycin Deprescribing Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years) with respiratory tract infections receiving azithromycin.
• Patients receiving azithromycin either empirically or based on culture and sensitivity results.

You may not qualify if:

• Patients falling outside the selected age group (below 18 years or above 65 years).
• Patients receiving azithromycin who are not willing to participate in the study.
• Pregnant or lactating women, as deprescribing or dose adjustment could lead to a risk.
• Patients enrolled in other interventional studies that could affect azithromycin therapy or clinical outcomes.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

Pakistan Institute of Medical Sciences (PIMS)

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Respiratory Tract Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Farman Ullah Khan

  CAPITAL UNIVERSITY OF SCIENCE AND TECHNOLOGY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Impact of Pharmacist-Led Multidisciplinary Deprescribing Strategy for Optimizing Azithromycin Use in Adult Patients With Respiratory Tract Infections: A Randomized Controlled Trial

Model Details: The intervention model involves patient assessment, pharmacist review, discussion with the treating physician/GP, and a recommendation to continue, optimize, or discontinue azithromycin, followed by reassessment at 48-72 hours and at the end of therapy (Day 5-7) to evaluate treatment outcomes.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)