COPDCDANCT07708337
Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD
A study testing 7-day antibiotic course and 14-day antibiotic course in people with COPD and Acute Exacerbation of COPD, run by Capital Development Authority (CDA) at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD, Acute Exacerbation of COPD
- What is being tested?
- 7-day antibiotic course and 14-day antibiotic course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Oct 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Physician-diagnosed COPD, confirmed by post-bronchodilator spirometry (FEV1/FVC < 0.70) where available, or by documented previous spirometry consistent with COPD.
- A current acute exacerbation of COPD for which the treating physician judges antibiotic therapy to be necessary, with at least two of the three cardinal symptoms (increased dyspnoea, increased sputum volume, increased sputum purulence).
- Able and willing to give written informed consent and to follow the study procedures and follow-up schedule.
Who cannot join
- A documented infection that requires a defined, longer antibiotic course, such as pneumonia with complications, an exacerbation of bronchiectasis, lung abscess or empyema.
- Need for immediate admission to intensive care or for invasive mechanical ventilation at presentation.
- Severe immunosuppression, for example neutropenia, active malignancy under chemotherapy, organ transplantation or advanced HIV infection.
- Suspected or confirmed pulmonary tuberculosis, or another respiratory infection that needs a different antimicrobial approach.
- Pregnancy or breastfeeding.
- Previous enrolment in this trial, or current participation in another interventional trial in AECOPD.
- Systemic antibiotic treatment for the current exacerbation started more than 48 hours before randomisation.
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
CDA Hospital Islamabad
Islamabad, Pakistan, 44000
Dr Fazal Rabbi, +923035646227, faiz@bjmu.edu.cn
About this study
Official title: Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD: Protocol for Randomized Controlled Trial
The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. The trial takes place at CDA Hospital Islamabad, Pakistan.
The main questions it aims to answer are:
Read more
- Do patients who take antibiotics for 7 days recover as well by Day 30 as patients who take them for 14 days?
- Does the shorter course lead to fewer side effects and less antibiotic use, without more treatment failures, relapses or hospital readmissions? Researchers will compare a 7-day antibiotic course with the usual 14-day course to see if the shorter course is just as effective.
Participants will:
- Be assigned by chance (like flipping a coin) to take antibiotics for either 7 days or 14 days. Their doctor chooses which antibiotic to use.
- Receive all other usual hospital care for their COPD flare-up.
- Have check-ups about 3-5 days, 7 days, 14 days and 30 days after joining the trial, in hospital or by telephone, to record their symptoms, any side effects and any return to hospital.
About 560 adults will take part.
Read the detailed description
Background: Antibiotics are routinely given to adults hospitalised with an acute exacerbation of COPD (AECOPD). International guidance (GOLD) advises that treatment should normally last about 5 days, but in many hospitals in Pakistan courses of 14 days remain usual practice. Longer courses increase antibiotic exposure, adverse effects and the risk of antimicrobial resistance, yet there is no randomised evidence from Pakistan on whether a shorter course is as effective for hospitalised patients.
Intervention: The experimental arm receives a 7-day systemic antibiotic course and the active comparator arm the conventional 14-day course. The treating physician chooses the agent, dose and route according to institutional practice and available microbiology, so only the planned duration differs between arms. Duration is counted from the first antibiotic dose for the current exacerbation. All other care, including bronchodilators, corticosteroids, oxygen and ventilatory support, follows usual practice in both arms. The intervention was developed through a three-round Delphi consensus process with prescribers before the trial began.
Procedures: Blood and sputum samples are taken at baseline for culture and susceptibility testing; results may guide a change of agent but do not change the allocated duration. Participants are assessed during treatment (Day 3-5), at Day 7, at Day 14 and at Day 30, in hospital or by telephone. Allocation uses a computer-generated sequence with permuted blocks of variable size, concealed through a web-based randomisation system.
Sample size: Assuming 80% clinical success in both arms, a non-inferiority margin of 10 percentage points, a one-sided alpha of 0.025 and 80% power, 252 evaluable participants per arm are required; allowing for 10% attrition, 560 participants will be enrolled.
Analysis: The primary analysis estimates the risk difference in clinical success at Day 30 (7-day minus 14-day) with a two-sided 95% Miettinen-Nurminen confidence interval. Non-inferiority will be concluded only if the lower confidence limit exceeds -10 percentage points in both the intention-to-treat and per-protocol populations. Full details are given in the study protocol (version 2.0) and statistical analysis plan (version 1.1).
- Conditions
- COPD, Acute Exacerbation of COPD
- Being tested
- 7-day antibiotic course, 14-day antibiotic course
- Keywords
- COPD, ACOPD, Antibiotic duration, Pakistan, ICU
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day antibiotic courseDrug
Systemic antibiotic therapy is given for a total of 7 days, counted from the first dose for the current exacerbation. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the comparator.
14-day antibiotic courseDrug
Systemic antibiotic therapy given for a total of 14 days, counted from the first dose for the current exacerbation, which is usual practice at the study hospital. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| 7-day antibiotic course | Experimental | Participants receive systemic antibiotic therapy for a total of 7 days, counted from the first dose for the current exacerbation. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice. Receives: Drug: 7-day antibiotic course |
| 14-day antibiotic course | Active comparator | Participants receive systemic antibiotic therapy for a total of 14 days, counted from the first dose for the current exacerbation, which is the usual practice at the study hospital. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice. Receives: Drug: 14-day antibiotic course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at Day 30
Number and proportion of participants with clinical success at Day 30 (±3 days) after randomisation, compared between arms as a risk difference (7-day minus 14-day) with a non-inferiority margin of -10 percentage points. Clinical success requires all of: (a) resolution or substantial improvement of the exacerbation-related signs and symptoms present at baseline (dyspnoea, sputum volume and sputum purulence), judged by the blinded outcome assessor using predefined criteria, with a reduction of at least 2 points from baseline in the COPD Assessment Test score; (b) no additional or alternative systemic antibiotic for a respiratory indication after the allocated course, and no extension of the course because of lack of improvement; (c) no hospital readmission or emergency department visit for AECOPD; and (d) the participant is alive. Participants who do not meet all four criteria are classified as clinical failures.
Measured: Day 30 (±3 days) after randomisation
Secondary outcomes (8)
Clinical Success at Day 14
Number and proportion of participants with clinical success at Day 14 (±2 days) after randomisation, defined as for the primary outcome, compared between arms as a risk difference.
Measured: Day 14 (±2 days) after randomisation
Time to Resolution of Exacerbation Symptoms
Number of days from randomisation to resolution of the exacerbation symptoms present at baseline.
Measured: From randomisation up to Day 30
Incidence of Antibiotic-Related Adverse Events and Serious Adverse Events
Number of participants with at least one adverse event or serious adverse event related to antibiotic treatment.
Measured: From randomisation up to Day 30
Treatment Failure
Number of participants with treatment failure, defined as the need for additional or alternative systemic antibiotics because of clinical deterioration or lack of improvement, escalation to non-invasive or invasive ventilation or intensive care after Day 3, or death.
Measured: From randomisation up to Day 30
Relapse
Number of participants with a new or worsening exacerbation requiring systemic antibiotics or corticosteroids after initial clinical improvement.
Measured: From randomisation up to Day 30
Rehospitalisation for Any Cause and for AECOPD
Number of participants readmitted to hospital, reported separately for any cause and for acute exacerbation of COPD.
Measured: Within 30 days after randomisation
All-Cause Mortality
Number of participants who die from any cause.
Measured: Within 30 days after randomisation
Total Antibiotic Consumption
Total systemic antibiotic consumption per participant, expressed in defined daily doses (DDD).
Measured: From randomisation up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start26 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Two-arm, parallel-group, randomised non-inferiority trial. Participants are allocated 1:1 to a 7-day or 14-day antibiotic course and followed for 30 days.
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Development Authority (CDA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazal Rabbi, Capital Development Authority (CDA)
- Investigators
- Fazal Rabbi, MD, Principal investigator, Capital Development Authority (CDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708337
- Sponsor's protocol ID
- IRB-113-07-08-25
- Acronym
- CDA
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available to researchers on reasonable request to the corresponding author after publication, subject to institutional and ethical approval.
Publications
Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. Lancet. 2025 May 17;405(10491):e19-e27. doi: 10.1016/S0140-6736(25)00770-6. Epub 2025 Apr 28.
PubMed 42290521Wang Y, Zijp TR, Bahar MA, Kocks JWH, Wilffert B, Hak E. Effects of prophylactic antibiotics on patients with stable COPD: a systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2018 Dec 1;73(12):3231-3243. doi: 10.1093/jac/dky326.
PubMed 30189002Vanoverschelde A, Van Hoey C, Buyle F, Den Blauwen N, Depuydt P, Van Braeckel E, Lahousse L. In-hospital antibiotic use for severe chronic obstructive pulmonary disease exacerbations: a retrospective observational study. BMC Pulm Med. 2023 Apr 25;23(1):138. doi: 10.1186/s12890-023-02426-3.
PubMed 37098509
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD: Protocol for Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07708337
- Acronym / sponsor ID
- CDA / IRB-113-07-08-25
- Conditions
- COPD, Acute Exacerbation of COPD
- Keywords
- COPD, ACOPD, Antibiotic duration, Pakistan, ICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Capital Development Authority (CDA)University, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. The trial takes place at CDA Hospital Islamabad, Pakistan.
The main questions it aims to answer are:
- Do patients who take antibiotics for 7 days recover as well by Day 30 as patients who take them for 14 days?
- Does the shorter course lead to fewer side effects and less antibiotic use, without more treatment failures, relapses or hospital readmissions? Researchers will compare a 7-day antibiotic course with the usual 14-day course to see if the shorter course is just as effective.
Participants will:
- Be assigned by chance (like flipping a coin) to take antibiotics for either 7 days or 14 days. Their doctor chooses which antibiotic to use.
- Receive all other usual hospital care for their COPD flare-up.
- Have check-ups about 3-5 days, 7 days, 14 days and 30 days after joining the trial, in hospital or by telephone, to record their symptoms, any side effects and any return to hospital.
About 560 adults will take part.
Detailed description
Background: Antibiotics are routinely given to adults hospitalised with an acute exacerbation of COPD (AECOPD). International guidance (GOLD) advises that treatment should normally last about 5 days, but in many hospitals in Pakistan courses of 14 days remain usual practice. Longer courses increase antibiotic exposure, adverse effects and the risk of antimicrobial resistance, yet there is no randomised evidence from Pakistan on whether a shorter course is as effective for hospitalised patients.
Intervention: The experimental arm receives a 7-day systemic antibiotic course and the active comparator arm the conventional 14-day course. The treating physician chooses the agent, dose and route according to institutional practice and available microbiology, so only the planned duration differs between arms. Duration is counted from the first antibiotic dose for the current exacerbation. All other care, including bronchodilators, corticosteroids, oxygen and ventilatory support, follows usual practice in both arms. The intervention was developed through a three-round Delphi consensus process with prescribers before the trial began.
Procedures: Blood and sputum samples are taken at baseline for culture and susceptibility testing; results may guide a change of agent but do not change the allocated duration. Participants are assessed during treatment (Day 3-5), at Day 7, at Day 14 and at Day 30, in hospital or by telephone. Allocation uses a computer-generated sequence with permuted blocks of variable size, concealed through a web-based randomisation system.
Sample size: Assuming 80% clinical success in both arms, a non-inferiority margin of 10 percentage points, a one-sided alpha of 0.025 and 80% power, 252 evaluable participants per arm are required; allowing for 10% attrition, 560 participants will be enrolled.
Analysis: The primary analysis estimates the risk difference in clinical success at Day 30 (7-day minus 14-day) with a two-sided 95% Miettinen-Nurminen confidence interval. Non-inferiority will be concluded only if the lower confidence limit exceeds -10 percentage points in both the intention-to-treat and per-protocol populations. Full details are given in the study protocol (version 2.0) and statistical analysis plan (version 1.1).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomised non-inferiority trial. Participants are allocated 1:1 to a 7-day or 14-day antibiotic course and followed for 30 days.
| Arm | Type | Receives |
|---|---|---|
| 7-day antibiotic course | Experimental | Drug: 7-day antibiotic courseParticipants receive systemic antibiotic therapy for a total of 7 days, counted from the first dose for the current exacerbation. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice. |
| 14-day antibiotic course | Active comparator | Drug: 14-day antibiotic courseParticipants receive systemic antibiotic therapy for a total of 14 days, counted from the first dose for the current exacerbation, which is the usual practice at the study hospital. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Physician-diagnosed COPD, confirmed by post-bronchodilator spirometry (FEV1/FVC < 0.70) where available, or by documented previous spirometry consistent with COPD.
- A current acute exacerbation of COPD for which the treating physician judges antibiotic therapy to be necessary, with at least two of the three cardinal symptoms (increased dyspnoea, increased sputum volume, increased sputum purulence).
- Able and willing to give written informed consent and to follow the study procedures and follow-up schedule.
Key exclusion criteria (7 listed)
- A documented infection that requires a defined, longer antibiotic course, such as pneumonia with complications, an exacerbation of bronchiectasis, lung abscess or empyema.
- Need for immediate admission to intensive care or for invasive mechanical ventilation at presentation.
- Severe immunosuppression, for example neutropenia, active malignancy under chemotherapy, organ transplantation or advanced HIV infection.
- Suspected or confirmed pulmonary tuberculosis, or another respiratory infection that needs a different antimicrobial approach.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-day antibiotic courseSystemic antibiotic therapy is given for a total of 7 days, counted from the first dose for the current exacerbation. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the comparator. | Drug | 7-day antibiotic course |
| 14-day antibiotic courseSystemic antibiotic therapy given for a total of 14 days, counted from the first dose for the current exacerbation, which is usual practice at the study hospital. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the experimental arm. | Drug | 14-day antibiotic course |
Primary outcome
Clinical Success at Day 30
Time frame: Day 30 (±3 days) after randomisation
Number and proportion of participants with clinical success at Day 30 (±3 days) after randomisation, compared between arms as a risk difference (7-day minus 14-day) with a non-inferiority margin of -10 percentage points. Clinical success requires all of: (a) resolution or substantial improvement of the exacerbation-related signs and symptoms present at baseline (dyspnoea, sputum volume and sputum purulence), judged by the blinded outcome assessor using predefined criteria, with a reduction of at least 2 points from baseline in the COPD Assessment Test score; (b) no additional or alternative systemic antibiotic for a respiratory indication after the allocated course, and no extension of the course because of lack of improvement; (c) no hospital readmission or emergency department visit for AECOPD; and (d) the participant is alive. Participants who do not meet all four criteria are classified as clinical failures.
8 secondary outcomes
Clinical Success at Day 14
Time frame: Day 14 (±2 days) after randomisation
Time to Resolution of Exacerbation Symptoms
Time frame: From randomisation up to Day 30
Incidence of Antibiotic-Related Adverse Events and Serious Adverse Events
Time frame: From randomisation up to Day 30
Treatment Failure
Time frame: From randomisation up to Day 30
Relapse
Time frame: From randomisation up to Day 30
Rehospitalisation for Any Cause and for AECOPD
Time frame: Within 30 days after randomisation
All-Cause Mortality
Time frame: Within 30 days after randomisation
Total Antibiotic Consumption
Time frame: From randomisation up to Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 42290521Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. Lancet. 2025 May 17;405(10491):e19-e27. doi: 10.1016/S0140-6736(25)00770-6. Epub 2025 Apr 28.
- Background: PubMed 30189002Wang Y, Zijp TR, Bahar MA, Kocks JWH, Wilffert B, Hak E. Effects of prophylactic antibiotics on patients with stable COPD: a systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2018 Dec 1;73(12):3231-3243. doi: 10.1093/jac/dky326.
- Background: PubMed 37098509Vanoverschelde A, Van Hoey C, Buyle F, Den Blauwen N, Depuydt P, Van Braeckel E, Lahousse L. In-hospital antibiotic use for severe chronic obstructive pulmonary disease exacerbations: a retrospective observational study. BMC Pulm Med. 2023 Apr 25;23(1):138. doi: 10.1186/s12890-023-02426-3.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available to researchers on reasonable request to the corresponding author after publication, subject to institutional and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fazal Rabbi, MD principal investigator
Capital Development Authority (CDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day antibiotic course and 14-day antibiotic course in people with COPD and Acute Exacerbation of COPD, run by Capital Development Authority (CDA) at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fazal Rabbi, MD (+923035646227, faiz@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at Day 30 (time frame: Day 30 (±3 days) after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07708337, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.