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Cephalosporin Antibiotic

High-Dose Cephalexin for Cellulitis (HI-DOCC Trial)

Phase 4
Waitlist Available
Led By Krishan Yadav, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (age ≥18 years) diagnosed with non-purulent cellulitis and determined by the treating emergency physician to be eligible for outpatient oral antibiotics.
Be older than 18 years old
Must not have
Surgical site infection
Solid organ or bone marrow transplant recipient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at day 8 and day 30
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial found that cellulitis is very common, and has a high cost to healthcare systems due to frequent hospital admissions.

Who is the study for?
This trial is for adults over 18 with non-purulent cellulitis who can take oral antibiotics at home. It's not for those under 18, on current antibiotics, needing IV treatment or surgery, with a history of MRSA-related cellulitis, cephalosporin allergy, unable to consent, undergoing chemotherapy for cancer, having symptoms in both legs, from penetrating wounds or water exposure related infections or severe kidney issues.
What is being tested?
The HI-DOCC study tests whether high doses of Cephalexin are effective in treating cellulitis without hospital admission. The goal is to see if this approach can reduce the healthcare burden by managing more cases as outpatients.
What are the potential side effects?
Cephalexin may cause side effects like digestive upset (nausea and diarrhea), skin reactions (rash), and rarely severe allergic reactions. Kidney function might also be affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with cellulitis and can be treated with oral antibiotics at home.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an infection at a recent surgery site.
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I have received a solid organ or bone marrow transplant.
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I am currently taking oral antibiotics.
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I have an abscess that needed to be cut open and drained.
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I am currently receiving chemotherapy for cancer.
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I have a skin infection from a human or animal bite.
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I am under 18 years old.
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I have a skin infection from a cut or after being in water.
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Both of my legs are affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at day 8 and day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at day 8 and day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Oral Antibiotic Treatment Failure
Secondary study objectives
Number of Participants with adverse events
Number of Participants with antibiotic allergy
Number of Participants with antibiotic intolerance
+4 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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose CephalexinExperimental Treatment1 Intervention
The intervention is high-dose cephalexin (1000mg PO QID) for seven days
Group II: Standard Dose CephalexinActive Control1 Intervention
The comparator is standard-dose cephalexin (500mg PO QID) plus oral placebo for seven days
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?

The Ottawa Hospital Academic Medical AssociationOTHER
23 Previous Clinical Trials
2,510 Total Patients Enrolled
1 Trials studying Cellulitis
66 Patients Enrolled for Cellulitis
Network of Canadian Emergency Researchers (NCER)UNKNOWN
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,502 Total Patients Enrolled
1 Trials studying Cellulitis
66 Patients Enrolled for Cellulitis
Krishan Yadav, MDPrincipal InvestigatorOttawa Hospital Research Institute

Media Library

Cephalexin (Cephalosporin Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05852262 — Phase 4
Cellulitis Research Study Groups: High Dose Cephalexin, Standard Dose Cephalexin
Cellulitis Clinical Trial 2023: Cephalexin Highlights & Side Effects. Trial Name: NCT05852262 — Phase 4
Cephalexin (Cephalosporin Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852262 — Phase 4
~149 spots leftby Aug 2025
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