Omission of prophylactic cefuroxime 1.5 g before transperineal prostate biopsy,
does it really help with Noninferiority for sepsis or urinary tract infection requiring hospitalization within two months?
research showsThe grade is B with 72 points. Hospital-requiring sepsis or UTI occurred in 0 patients in both groups, risk difference 0 points (95% CI -1.37 to 1.37). The upper bound was below the prespecified 4-point noninferiority margin.
ads claimReducing antibiotic exposure lowers individual adverse effects and population selection pressure for resistance. Verdict 2402 is C with 56 points and asks about cefazolin timing in cesarean delivery, not antibiotic omission in transperineal biopsy. `1175` concerns the same antibiotic, cefuroxime, but asks whether direct intracameral administration at the end of cataract surgery prevents endophthalmitis. This verdict asks whether systemic prophylactic antibiotics can be omitted before transperineal prostate biopsy. These are entirely different questions.
Useful facts when choosing a product
- Biopsy used an outpatient transperineal MRI-TRUS fusion approach under local anesthesia.
- Cefuroxime was intramuscular in Norway and intravenous in Germany.
- The result does not apply to transrectal biopsy or high-risk infection patients.
What the research actually shows
NORAPP randomized 555 patients at two Norwegian and German hospitals and analyzed 553 eligible randomized participants after excluding two with an unknown allergy. It was open label, not placebo-controlled or double-blind, but the primary endpoint required hospitalization and was not counted as an unblinded subjective endpoint. Limitation name: noninferiority design. Listed item: prespecified margin 4 percentage points. Avoidability: possible - a larger superiority or equivalence design could rely less on an accepted increase in infection. Small study (<200) does not apply (553); substantial attrition (>=15%) was 2/555 (0.36%) and does not apply. Oslo University Hospital and Vivantes Klinikum Am Urban provided public-hospital funding.
Why this is classified as B (72)
A hospital-requiring infection endpoint, public funding, 553 analyzed participants, and a met 4-point margin are strengths; one noninferiority trial limits the grade to B with 72 points.
Counterpoint. Zero versus zero does not mean zero risk; each group had a 95% CI upper bound of 1.37%.
Rejudgment record. New verdict — Zero hospital-requiring infections in both transperineal groups, 553 analyzed participants, a 1.37-point CI upper bound, and a prespecified 4-point margin
| Endpoint | H | Hard endpoint - actual events such as death |
| Replication | R1 | Single confirmatory trial |
| Independence | I2 | Decisive evidence is publicly or non-profit funded |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (B).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Antibiotic omission for transperineal biopsy | B | Noninferiority for hospital-requiring infection was met. |
Cross-check — Codex and Claude
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Study 1 | Randomized open-label noninferiority trial | 553 | Oslo University Hospital and Vivantes Klinikum Am Urban | Sepsis or UTI requiring hospitalization within two months | 0% versus 0%; risk difference 0 points (95% CI -1.37 to 1.37); margin 4 points | Pivotal antibiotic-omission trial |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-18).
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-18 · Corrections: none
Cite this verdict
[Chamgap] Omitting Prophylactic Cefuroxime Before Transperineal Prostate Biopsy Is Noninferior for Hospital-Requiring Sepsis or Urinary Tract Infection - Benefit — Evidence Grade B·72. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/mens/omit-cefuroxime-transperineal-prostate-biopsy-hospital-infection-norapp/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.