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Antibiotic

Cephalexin for Surgical Site Infection (PACT Trial)

Phase 1
Waitlist Available
Led By Antonio F Saad, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks (42 days) postpartum
Awards & highlights

PACT Trial Summary

This trial will test whether adding a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics will improve surgical site infection rates in obese patients who have undergone Cesarean section after laboring.

Eligible Conditions
  • Surgical Site Infections

PACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks (42 days) postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks (42 days) postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical site infection
Secondary outcome measures
Febrile morbidity
Maternal mortality
Other adverse events
+3 more

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

PACT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cephalexin and metronidazoleExperimental Treatment2 Interventions
500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses
Group II: Placebo / standard of carePlacebo Group1 Intervention
Placebo pills per oral every 8 hours for a total of 6 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cephalexin
FDA approved
Metronidazole
FDA approved

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,270 Total Patients Enrolled
Antonio F Saad, MDPrincipal InvestigatorUniversity of Texas
5 Previous Clinical Trials
978 Total Patients Enrolled

Frequently Asked Questions

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

Is the age requirement of this experimental research limited to those below 40?

"Eligible individuals for this experiment must be over 18 years old and no older than 50."

Answered by AI

How deleterious is Cephalexin usage to people's wellbeing?

"To indicate the potential risks of this experimental drug, our team gave Cephalexin a score of 1. This is due to Phase 1 trials only having minimal amounts of research supporting its efficacy and safety."

Answered by AI

Are there any openings presently available to join this experimentation?

"This trial is open for recruitment, as indicated by clinicaltrials.gov; the initial posting was on August 1st 2017 and the information has since been updated on August 18th 2022."

Answered by AI

What is the highest number of participants in this trial?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this medical trial, which was initially posted on August 1st 2017, is actively recruiting for 332 participants from 2 locations."

Answered by AI

Am I eligible to enroll in this experiment?

"This medical research requires 332 individuals between 18 and 50 years of age who currently have communicable diseases. Prospective participants must fulfill the following prerequisites: greenlighted Cesarean delivery by a clinical team, rupture in membranes (ROM) within 24 hours after commencement or during labor (spontaneous ROM or initiated with artificial intervention), BMI greater than 30kg/m2, and minimum age of eighteen years old and maximum of fifty."

Answered by AI

What medical conditions has Cephalexin demonstrated efficacy in treating?

"Trichomoniasis can be treated with cephalexin, a drug which also has the potential to mitigate dermatitis and protect against postoperative infections or tetanus."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prophylactic Antibiotics After Cesarean
2017. "Prophylactic Antibiotics After Cesarean". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03187106.
~42 spots leftby Apr 2025
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