Respiratory Tract DiseasesRCTNCT07849491
Impact of Pharmacist Led Multidisciplinary Deprescribing Strategy in Patients With Respiratory Tract Infections
A study testing Pharmacist-Led Azithromycin Deprescribing Intervention in people with Respiratory Tract Diseases, run by Xi'an Jiaotong University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Pharmacist-Led Azithromycin Deprescribing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-65 years) with respiratory tract infections receiving azithromycin.
- Patients receiving azithromycin either empirically or based on culture and sensitivity results.
- Patients who are clinically stable and do not require ICU-level care at the time of inclusion
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Institute of Medical Sciences (PIMS)
Islamabad, Islamabad, 44000
About this study
Official title: Impact of Pharmacist-Led Multidisciplinary Deprescribing Strategy for Optimizing Azithromycin Use in Adult Patients With Respiratory Tract Infections: A Randomized Controlled Trial
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.
Read the detailed description
Azithromycin is commonly prescribed for respiratory tract infections because of its broad-spectrum coverage and convenient dosing. However, inappropriate and empirical use may contribute to antimicrobial resistance, treatment failure, and safety concerns. Deprescribing involves the rational reduction or discontinuation of medicines when they are unnecessary or when continued treatment may not be appropriate. Pharmacist-led antimicrobial stewardship may help optimize antibiotic therapy through structured medication review and reassessment.
This study is a prospective, open-label, randomized controlled trial designed to evaluate the impact of a pharmacist-led multidisciplinary deprescribing strategy on azithromycin use in adult patients with respiratory tract infections. The study will be conducted in tertiary care hospitals in Islamabad, Pakistan.
The study will enroll clinically stable adults aged 18-65 years with respiratory tract infections who have been prescribed azithromycin as part of their treatment. A total of 200 participants will be randomly allocated to either the intervention group (n=100) or the control group (n=100).
Participants in the intervention group will receive a pharmacist-led deprescribing intervention in collaboration with physicians. The intervention will include medication review and reassessment of azithromycin therapy, with consideration of dose optimization or discontinuation when appropriate. The final decision regarding modification or discontinuation of therapy will be made in collaboration with the treating physician. Participants in the control group will receive usual physician-directed care without the structured deprescribing intervention.
Participants in both groups will be followed at 48-72 hours and again at the end of therapy. These assessments will evaluate clinical response and safety during treatment.
The primary outcomes will be appropriate azithromycin use, clinical cure, and treatment failure. Secondary outcomes will include adverse drug reactions, medication adherence, symptomatic improvement, and quality of life. Data will be collected using demographic information, patient medical records, laboratory reports, the General Medication Adherence Scale (GMAS), and the EQ-5D-3L quality-of-life instrument.
Appropriate azithromycin use will be assessed according to the study protocol, while clinical cure and treatment failure will be evaluated during follow-up. Safety will be assessed through the occurrence of adverse drug reactions and relevant clinical or laboratory findings. Medication adherence and quality of life will also be assessed during the study follow-up.
The study will compare outcomes between participants receiving the pharmacist-led multidisciplinary deprescribing intervention and those receiving usual physician-directed care. Statistical analyses will use appropriate parametric or non-parametric tests according to the distribution and characteristics of the collected data.
- Conditions
- Respiratory Tract Diseases
- Being tested
- Pharmacist-Led Azithromycin Deprescribing Intervention
- Keywords
- Azithromycin, Respiratory Tract Infections, Antibiotic Deprescribing
- Medical subject headings
- Respiratory Tract Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led Azithromycin Deprescribing InterventionDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pharmacist-Led Azithromycin Deprescribing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 5-7
Secondary outcomes (3)
Quality of Life of Participants a who are a part of this study
Change in health-related quality of life assessed using the EQ-5D-3L questionnaire.
Measured: Baseline through 48-72 hours till end of the therapy (5-7 days)
Medication Adherence
Medication adherence assessed using the General Medication Adherence Scale (GMAS).
High Adherence: 30-33 score on scale Partial adherence: 17-26 score on scale Poor Adherence: 0-10 score on scale
Measured: Baseline through 48-72 hours till end of the therapy (5-7 days)
Symptomatic Resolution
Proportion of pharmacist recommendations that are accepted and implemented by the treating physician/GP.
Measured: Baseline through 48-72 hours till end of the therapy (5-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 May 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farman Ullah Khan, CAPITAL UNIVERSITY OF SCIENCE AND TECHNOLOGY
- Investigators
- Farman Ullah Khan, Principal investigator, CAPITAL UNIVERSITY OF SCIENCE AND TECHNOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849491
- Sponsor's protocol ID
- F-5-2/2024(ERRC)/PIMS
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because no data-sharing plan has been established for this study. Participant confidentiality and privacy will be maintained, and study results will be reported in aggregate form.