Indwelling Pleural Catheters With or Without Doxycycline for Malignant Pleural Effusions
This study is looking at how well indwelling pleural catheters (IPCs), which are tubes placed to drain fluid from around the lungs, work to treat malignant pleural effusions (MPE), which is fluid buildup caused by cancer. It compares using IPCs alone versus using IPCs with doxycycline, an antibiotic that can also help reduce fluid buildup. The main goal is to see if adding doxycycline can shorten the time you need to have the IPC in place. You may be able to join if you are an outpatient getting an IPC or an inpatient expected to go home soon after getting one. The study is currently observing patients, and aims to enroll 208 participants.
- Study design
- This is an observational study, meaning participants choose one of two groups: IPC alone or IPC with doxycycline. It aims to enroll 208 participants.
- What's involved
- You will receive an indwelling pleural catheter. If you are in Group I, you will also receive doxycycline via the IPC 5 days later. You will have follow-up visits at 10-14 days and then monthly for up to a year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up at 10-14 days and then monthly for up to a year after treatment.
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Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- David Ost · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Time to pleural catheter removalUp to 1 year
This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal.