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BACE Trial Substudy 1 - PROactive Substudy

NCT02205242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-08

No results posted yet for this study

Summary

A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of the intervention study with portable validated activity monitors.

Conditions

Interventions

DRUG

Azithromycin

From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days

DEVICE

Dynaport®

Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months

DRUG

Placebo

Sponsors & Collaborators

  • Pro-Active Medical Pty Ltd

    collaborator INDUSTRY

  • Wim Janssens

    lead OTHER

Principal Investigators

  • Wim Janssens, MD PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-04-30
Completion
2020-04-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205242 on ClinicalTrials.gov