ClinicalTrials.gg
Status unknownNCT02937181Updated Oct 28, 2016

Antibiotic Prophylaxis in Open Fractures

A Phase 4 interventional study of Ceftaroline in Open Fractures, sponsored by Olayemi Osiyemi MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Olayemi Osiyemi MD · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures

Read the detailed description

Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy

02

Conditions studied

  • Open Fractures

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03

In context

Fractures, Open

53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.

Browse Fractures, Open studies →

Lead sponsor

Olayemi Osiyemi MD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male or female >= 18 years old
  • complete an
  • patients are diagnosed with a type II or III open fracture

Exclusion criteria

Exclusion Criteria:

  • allergy to beta-lactam antibiotics prior to screening
  • prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
  • pregnant female
  • inability to provide consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    open fractures type II and III

    Every patients will receive Ceftaroline in an open label, single arm

    Drug: Ceftaroline

Interventions

  • IV Ceftaroline will be given for 72 hours

    Also known as: Teflaro

06

What researchers measure

Primary outcomes

  1. Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate

    Time frame: 30 days

Secondary outcomes

  1. Incidence of acute kidney injury

    Time frame: 30 days

Other outcomes

  1. Identify bacteria associated with the infections

    Time frame: 30 days

  2. identify the number of infections associated with sites other than fracture site

    Time frame: 30 days

07

Study locations

1 site
  • Triple O Research Institute PA
    West Palm Beach, Florida 33401, United States
08

References and documents

Individual participant data

Plan to share: Yes — no personal data, identifier and the data are made available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02937181
Lead sponsor
Olayemi Osiyemi MD
Collaborators
Forest Laboratories
Responsible party
Olayemi Osiyemi MD (President/, Triple O Research Institute PA) — Sponsor-investigator
First posted
Oct 18, 2016
Start date
Dec 2016
Primary completion
Oct 2018 (estimated)
Completion
Mar 2019 (estimated)
Last update
Oct 28, 2016

Study contacts

Paul Glickman
Contact
pglickman@tripleoresearch.com
561-855-7871
Olayemi Osiyemi, MD
Contact
drtripleo@tripleoresearch.com
561-855-7871
Olayemi Osiyemi, MD
principal investigator · Triple O Research Institute PA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ceftaroline

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