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Antibiotic

Cephalexin for Surgical Infection Prevention

Phase 2
Recruiting
Led By Merisa Piper, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial will test whether patients who have high abundance of Staphylococcus and/or Pseudomonas before surgery are more likely to get an infection from those organisms after surgery.

Who is the study for?
This trial is for adults over 18 with breast cancer or a genetic risk for it, who are planning to have mastectomy and immediate tissue expander or implant placement. They must be able to consent and at least 4 weeks post-chemo or radiation. Excluded are those with significant health risks, recent antibiotic use, pregnancy, breastfeeding, allergy to study antibiotics, males, and recent probiotic use.Check my eligibility
What is being tested?
The trial studies the link between the abundance of Staphylococcus/Pseudomonas in breast tissue microbiome before mastectomy and the risk of infection after placing tissue expanders/implants. Cephalexin's effectiveness against these infections is being tested.See study design
What are the potential side effects?
Cephalexin may cause side effects like digestive issues (diarrhea), allergic reactions (rashes), nausea, vomiting, dizziness, tiredness but varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of breast cancer or a genetic risk for it.
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I am 18 years old or older.
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I am scheduled for a mastectomy with immediate tissue expander or implant placement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)
Proportion of any samples successfully producing microbiome data
Proportion of aspirate samples obtained successfully overall
+3 more
Secondary outcome measures
Number of overall identified microbes
Proportion of participants with post-operative infection
Shannon Diversity Index Score for species of microbiome

Side effects data

From 2013 Phase 2 & 3 trial • 2265 Patients • NCT00729937
21%
Nausea
16%
Headache
15%
Diarrhoea
14%
Abscess
10%
Vomiting
7%
Dizziness
6%
Abdominal pain upper
4%
Constipation
3%
Pyrexia
3%
Rash
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abscess, Placebo
Abscess, TMP/SMX
Infected Wound, TMP/SMX
Infected Wound, Clindamycin
Cellulitis, Cephalexin and TMP/SMX
Cellulitis, Cephalexin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A: Standard antibioticsExperimental Treatment1 Intervention
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
Group II: Cohort B: No antibioticsActive Control1 Intervention
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cephalexin
2012
Completed Phase 4
~4070

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,355 Total Patients Enrolled
45 Trials studying Breast Cancer
3,828,235 Patients Enrolled for Breast Cancer
The Plastic Surgery FoundationOTHER
8 Previous Clinical Trials
947 Total Patients Enrolled
1 Trials studying Breast Cancer
352 Patients Enrolled for Breast Cancer
Merisa Piper, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Breast Cancer
150 Patients Enrolled for Breast Cancer

Media Library

Cephalexin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05020574 — Phase 2
Breast Cancer Research Study Groups: Cohort A: Standard antibiotics, Cohort B: No antibiotics
Breast Cancer Clinical Trial 2023: Cephalexin Highlights & Side Effects. Trial Name: NCT05020574 — Phase 2
Cephalexin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020574 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can Cephalexin be detrimental to human health?

"Cephalexin, which is in Phase 2 trials with data only supporting safety rather than efficacy, was assigned a score of 2."

Answered by AI

What therapeutic benefits can patients expect from utilizing Cephalexin?

"Cephalexin can be utilized to successfully treat streptococcus pneumoniae, otitis media (OM), and genitourinary tract infection."

Answered by AI

Are there any precedent investigations involving Cephalexin?

"Presently, there are 14 ongoing research projects related to Cephalexin with 3 of these trials at the Phase 3 level. The majority of these tests are being conducted from Morgantown, West virginia but 44 other sites have been identified for testing purposes."

Answered by AI

What are the primary objectives of this research endeavor?

"This clinical trial's salient endpoint is the proportion of aspirate samples able to generate microbiome data within a 90-day period. Secondary outcomes include: number of microbes identified, rate of participants with postoperative infection, and Shannon Diversity Index Score for species in the microbiome. The latter evaluates richness (number of operational taxonomic units) and evenness using lnpi proportions multiplied by -1 across all species present. This calculation yields an equitability between 0-1, represented as a percentage score relative to Hmax value (lnS)."

Answered by AI

What is the aggregate amount of persons involved in this experiment?

"Confirmed. According to clinicaltrials.gov, this ongoing medical trial was first published on September 28th 2021 and had a recent update on November 14th 2022. The 200 participants needed must be recruited from 1 site."

Answered by AI

Are volunteers currently being enrolled in the clinical trial?

"Affirmative. As seen on clinicaltrials.gov, this trial was initially posted on September 28th 2021 and is currently recruiting participants. The goal of the study is to include 200 patients from a single site."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Microbiome and Association With Implant Infections
2021. "Microbiome and Association With Implant Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020574.
All > Rsv > Microbiome
~78 spots leftby Dec 2025
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