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Cephalosporin Antibiotic
High-Dose Cephalexin for Cellulitis (HI-DOCC Trial)
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at day 8 and day 30
Awards & highlights
HI-DOCC Trial 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.Check my eligibility
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.See study design
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.
HI-DOCC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with cellulitis and can be treated with oral antibiotics at home.
HI-DOCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated at day 8 and day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at day 8 and day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Oral Antibiotic Treatment Failure
Secondary outcome measures
Number of Participants with adverse events
Number of Participants with antibiotic allergy
Number of Participants with antibiotic intolerance
+6 moreSide effects data
From 2013 Phase 2 & 3 trial • 2265 Patients • NCT0072993721%
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
HI-DOCC 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
22 Previous Clinical Trials
2,450 Total Patients Enrolled
1 Trials studying Cellulitis
66 Patients Enrolled for Cellulitis
Network of Canadian Emergency Researchers (NCER)UNKNOWN
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,048 Total Patients Enrolled
1 Trials studying Cellulitis
66 Patients Enrolled for Cellulitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is significantly reduced.I have an infection at a recent surgery site.My doctor has prescribed IV antibiotics for me.I have received a solid organ or bone marrow transplant.You are allergic to cephalosporins or have had a severe allergic reaction to penicillin.I am currently taking oral antibiotics.I have an abscess that needed to be cut open and drained.You have had a specific kind of skin infection caused by a type of bacteria called MRSA in the past.I am currently receiving chemotherapy for cancer.My follow-up visit showed a non-infectious condition like a blood clot.I have a skin infection from a human or animal bite.I am 18 or older with cellulitis and can be treated with oral antibiotics at home.I am under 18 years old.I have a skin infection from a cut or after being in water.Both of my legs are affected.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose Cephalexin
- Group 2: Standard Dose Cephalexin
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with the usage of high doses of Cephalexin?
"The safety of High Dose Cephalexin was rated a 3, due to its Phase 4 trial status. This indicates that the drug has been approved for use."
Answered by AI
Are there any spots left for potential participants in this clinical trial?
"Per the details found on clinicaltrials.gov, this trial has ceased actively seeking participants since May 1st 2023. The study was initially posted June 1st 2023 and is no longer looking for patients; however 9 other studies are currently enrolling volunteers."
Answered by AI
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