Appendicitis (Diagnosis)Phase 1PANDANCT06860802
Precision Antibiotic Dosing for Appendectomy
A Phase 1 study testing Cefoxitin in people with Appendicitis (Diagnosis), run by University of Michigan at 1 site in United States.
Trial summary
This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis (Diagnosis)
- What is being tested?
- Cefoxitin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan
Who cannot join
- Prisoners
- Patients that are pregnant
- Patients with perforation or abscess on CT Scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aim 3 - Precision Coordination of Therapeutic and Prophylactic Antibiotics to Reduce Infection, Toxicity, and Emergence of Resistance Following Acute Abdominal Surgery
This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. This research will compare the current standard treatment which is a single dose prior to surgery to a new method that includes adding another dose of cefoxitin within 30 minutes of starting the surgery. This study will measure cefoxitin concentrations in blood, fat, and appendix tissue samples to compare the standard dosing method to our new method. This information will help us figure out the right dose of this drug to prevent infection after surgery to remove an appendix.
Read the detailed description
This interventional, phase 1 study aims to improve surgical site infection (SSI) prevention in patients undergoing appendectomy for uncomplicated appendicitis. Despite standard antibiotic prophylaxis, SSI rates remain high, with a pelvic abscess risk of 9.4%. Current prophylactic antibiotic regimens may not achieve optimal tissue concentrations, especially in fat and appendix tissue.
This study will evaluate the probability of target attainment (PTA) of cefoxitin, cefuroxime, and metronidazole in plasma, subcutaneous fat, and appendix tissue. A cohort of 46 adult patients will be randomized to receive standard-of-care antibiotics with or without an additional cefoxitin dose. Antibiotic concentrations will be measured in collected blood, fat, and appendix samples.
The study's primary objective is to determine whether a supplemental cefoxitin dose improves PTA compared to standard prophylaxis. Population pharmacokinetic modeling will validate the intervention's effectiveness in optimizing antibiotic exposure and reducing SSI risk. The results may inform future precision antibiotic dosing strategies for appendectomy and other acute care surgeries.
Primary Outcome Measure:
Probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue between intervention and standard care groups.
Study Design:
Randomized, interventional, phase 1 study Enrollment: 46 participants Inclusion: Adults (>18 years) undergoing appendectomy for acute appendicitis Exclusion: Pregnant individuals, prisoners, patients with perforation or abscess This study seeks to improve perioperative antibiotic management, reducing SSI rates while minimizing unnecessary antibiotic exposure and resistance development.
- Conditions
- Appendicitis (Diagnosis)
- Being tested
- Cefoxitin
- Keywords
- Cefoxitin, Appendectomy, Surgical Site Infections
- Medical subject headings
- Appendicitis, Disease, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefoxitinDrug
Cefoxitin 2000 mg Bolus Injection
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The current standard of care surgical prophylaxis regimen |
| Cefoxitin | Experimental | Administration of Cefoxitin 2000 mg within 30 minutes of incision to the existing standard of care intervention Receives: Drug: Cefoxitin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue
The probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue in the intervention compared to the non-intervention (standard of care) arm.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start28 Feb 2025
- Primary completion31 Jul 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional phase 1 study design that includes human adult participants undergoing an appendectomy. The study entails collection and analysis of three blood (plasma) samples, two subcutaneous fat samples, and appendix tissue samples from resected surgical specimens. The intervention is to receive the standard of care surgical prophylaxis or the standard of care surgical prophylaxis plus the addition of cefoxitin 2000 mg within 30 minutes of incision
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Manjunath Prakash Pai, University of Michigan
- Investigators
- Manjunath Pai, PharmD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860802
- Sponsor's protocol ID
- HUM00263447
- Other IDs
- R01HS027788
- Acronym
- PANDA
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aim 3 - Precision Coordination of Therapeutic and Prophylactic Antibiotics to Reduce Infection, Toxicity, and Emergence of Resistance Following Acute Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06860802
- Acronym / sponsor ID
- PANDA / HUM00263447
- Conditions
- Appendicitis (Diagnosis)
- Keywords
- Cefoxitin, Appendectomy, Surgical Site Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. This research will compare the current standard treatment which is a single dose prior to surgery to a new method that includes adding another dose of cefoxitin within 30 minutes of starting the surgery. This study will measure cefoxitin concentrations in blood, fat, and appendix tissue samples to compare the standard dosing method to our new method. This information will help us figure out the right dose of this drug to prevent infection after surgery to remove an appendix.
Detailed description
This interventional, phase 1 study aims to improve surgical site infection (SSI) prevention in patients undergoing appendectomy for uncomplicated appendicitis. Despite standard antibiotic prophylaxis, SSI rates remain high, with a pelvic abscess risk of 9.4%. Current prophylactic antibiotic regimens may not achieve optimal tissue concentrations, especially in fat and appendix tissue.
This study will evaluate the probability of target attainment (PTA) of cefoxitin, cefuroxime, and metronidazole in plasma, subcutaneous fat, and appendix tissue. A cohort of 46 adult patients will be randomized to receive standard-of-care antibiotics with or without an additional cefoxitin dose. Antibiotic concentrations will be measured in collected blood, fat, and appendix samples.
The study's primary objective is to determine whether a supplemental cefoxitin dose improves PTA compared to standard prophylaxis. Population pharmacokinetic modeling will validate the intervention's effectiveness in optimizing antibiotic exposure and reducing SSI risk. The results may inform future precision antibiotic dosing strategies for appendectomy and other acute care surgeries.
Primary Outcome Measure:
Probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue between intervention and standard care groups.
Study Design:
Randomized, interventional, phase 1 study Enrollment: 46 participants Inclusion: Adults (>18 years) undergoing appendectomy for acute appendicitis Exclusion: Pregnant individuals, prisoners, patients with perforation or abscess This study seeks to improve perioperative antibiotic management, reducing SSI rates while minimizing unnecessary antibiotic exposure and resistance development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional phase 1 study design that includes human adult participants undergoing an appendectomy. The study entails collection and analysis of three blood (plasma) samples, two subcutaneous fat samples, and appendix tissue samples from resected surgical specimens. The intervention is to receive the standard of care surgical prophylaxis or the standard of care surgical prophylaxis plus the addition of cefoxitin 2000 mg within 30 minutes of incision
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The current standard of care surgical prophylaxis regimen |
| Cefoxitin | Experimental | Drug: CefoxitinAdministration of Cefoxitin 2000 mg within 30 minutes of incision to the existing standard of care intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan
Key exclusion criteria (3 listed)
- Prisoners
- Patients that are pregnant
- Patients with perforation or abscess on CT Scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefoxitinCefoxitin 2000 mg Bolus Injection | Drug | Cefoxitin |
Primary outcome
Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue
Time frame: 4 hours
The probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue in the intervention compared to the non-intervention (standard of care) arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manjunath Pai, PharmD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefoxitin in people with Appendicitis (Diagnosis), run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Achieving Optimal Antibiotic Concentration in Appendix Tissue (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.