NCT04301869

Brief Summary

We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

March 6, 2020

Last Update Submit

March 6, 2020

Conditions

Pleural Infection

Outcome Measures

Primary Outcomes (2)

  • Enrollment feasibility

    Proportion of eligible participants screened that are randomized within 5 days of initial intravenous antibiotic exposure

    3 months

  • Completion feasibility

    Proportion of participants with follow-up at 4 weeks either through a clinic visit or phone call

    3 months

Secondary Outcomes (7)

  • Treatment failure

    3 months

  • Mortality

    3 months

  • Antibiotic duration

    3 months

  • Hospitalization duration

    3 months

  • Stopping antibiotics

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Intravenous therapy

ACTIVE COMPARATOR

Intravenous antibiotics administered for pleural space infection

Drug: Antibiotics

Oral therapy

ACTIVE COMPARATOR

Oral antibiotics administered for pleural space infection

Drug: Antibiotics

Interventions

AntibioticsDRUG

Oral versus intravenous therapy

Intravenous therapyOral therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must meet our study definition of pleural space infection
  • Age \> or = 18 years old
  • Life expectancy \> 1 year
  • Received intravenous or oral antibiotics for = or \< 7 d from surgical intervention or received a total of = or \< 7 d of antibiotics if no intervention performed

You may not qualify if:

  • S. aureus bacteremia or endocarditis in the last 1 month
  • Another concomitant infection requiring prolonged IV antibiotics
  • Esophageal rupture or malignant pleural effusion
  • Septic shock or systemic features requiring IV antibiotics
  • Mycobacterial, fungal or parasitic pleural space infection
  • No oral antibiotic options available
  • Unlikely to comply with therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

May 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 10, 2020

Record last verified: 2020-03