Trimethoprim-Sulfamethoxazole (TMP-SMX)
DrugReceipt of tablet with the equivalent of one double-strength (DS) TMP-SMX(TMP 160mg + SMZ 800mg) per day by mouth for 4 weeks
Other names: Bactrim, Sulfatrim
NCT Number: NCT07665359
Previous researches have found the common colonization of Pneumocystis jirovecii (Pj) in the airways of people with chronic obstructive pulmonary disease (COPD). And this colonization may exacerbate airway inflammation and increase the frequency of acute exacerbation in people with COPD.
The goal of this clinical trial is to study if "decolonization treatment" (that is, removing these colonizing Pj) works to improve the prognosis of COPD colonized by Pj in adults. The main question it aims to answer is:
* Does the Trimethoprim-Sulfamethoxazole (TMP-SMX, an antibiotics) decolonization treatment reduce the frequency of acute exacerbation in participants with COPD colonized by Pj who have a high risk of acute exacerbation.
Researchers will compare TMP-SMX to a placebo (a look-alike substance that contains no drug) to see if TMP-SMX works to reduce the frequency of acute exacerbation of COPD.
Participants will:
* Take drug TMP-SMX or a placebo 2 tablet every day for 4 weeks. * Visit the clinic after 2 weeks, 1 month, 3 months, 6 months and 12 months for survey questions, checkups and tests. * Keep a diary of their symptoms and the number of times they experience acute exacerbations
Trial opening soon.
Get Notified40 year and older
All sexes
Interventional
Not applicable
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receipt of tablet with the equivalent of one double-strength (DS) TMP-SMX(TMP 160mg + SMZ 800mg) per day by mouth for 4 weeks
Other names: Bactrim, Sulfatrim
Receipt of tablet with placebo by mouth every day for 4 weeks
Time frame: Baseline (Day 1) to 12 months
Time frame: 1month
Time frame: 3 months,12 months
Time frame: 1month,3 months,6 months and 12 months
The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome.Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.
Time frame: 1month,3 months,6 months and 12 months
The mMRC scale consists of 5 grades (0-4), based on how much breathlessness limits physical activity. Higher mMRC scores mean a worse outcome.
Time frame: Baseline to 12 months
Time frame: Baseline to 1month and 12 months
The microbiome of qualified sputum will be measurable by metagenomic next-generation sequencing (mNGS) technologies. Its characteristic parameters include the alpha diversity and beta diversity of the microbiome.
Time frame: Baseline to 3 months,6 months and 12 months
Time frame: 2 weeks and 1 month
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
A Multicenter, Prospective, Double-blind, Randomized Controlled Study on the Impact of Decolonization Treatment on the Frequency of Acute Exacerbation in Patients With Chronic Obstructive Pulmonary Disease Colonized With Pneumocystis Jirovecii
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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