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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
All Individual Drugs Already Approved
Approved for 30 Other Conditions

Summary

This trial is testing if giving two types of antibiotics after surgery can reduce infections in women who have a Cesarean section after laboring. The antibiotics work by killing harmful bacteria to prevent infections.

Eligible Conditions
  • Surgical Site Infections

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical site infection
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

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
252 Previous Clinical Trials
56,565 Total Patients Enrolled
Antonio F Saad, MDPrincipal InvestigatorUniversity of Texas
5 Previous Clinical Trials
675 Total Patients Enrolled
~39 spots leftby Nov 2025
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