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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
246 Previous Clinical Trials
56,479 Total Patients Enrolled
Antonio F Saad, MDPrincipal InvestigatorUniversity of Texas
5 Previous Clinical Trials
978 Total Patients Enrolled
~41 spots leftby Jun 2025
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