Cohort Study
Low-dose penicillin for recurrent cellulitis
J Fam Pract. 2014;63:E9-E11
RCT
Potential PURL Review Form
PURLs Surveillance System
Family Physicians Inquiries Network
|SECTION 1: Identifying Information for Nominated Potential PURL |
|[to be completed by PURLs Project Manager] |
|1. Citation |Thomas KS, Crook AM, Nunn AJ, Foster KA, Mason JM, Chalmers JR, Nasr IS, Brindle RJ, English J, Meredith SK, Reynolds NJ, de |
| |Berker D, Mortimer PS, Williams HC; U.K. Dermatology Clinical Trials Network's PATCH I Trial Team. |
| |Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013 May 2;368(18):1695-703. doi: 10.1056/NEJMoa1206300. PubMed |
| |PMID: 23635049. |
|2. Hypertext link to | |
|PDF of full article | |
|3. First date published|5/2/13 |
|study available to | |
|readers | |
|4. PubMed ID |23635049 |
|5. Nominated By |Jim Stevermer Other: |
|6. Institutional |University of Missouri Other: |
|Affiliation of Nominator| |
|7. Date Nominated |5/8/13 |
|8. Identified Through |Info POEMs Other: |
|9. PURLS Editor |Kate Rowland Other: |
|Reviewing Nominated | |
|Potential PURL | |
|10. Nomination Decision |5/16/13 |
|Date | |
|11. Potential PURL |RCT |
|Review Form (PPRF) Type | |
|12. Other comments, | |
|materials or discussion | |
|13. Assigned Potential |Liz Nguyen |
|PURL Reviewer | |
|14. Reviewer Affiliation|University of Chicago Other: |
|15. Date Review Due |6/13/13 |
|16. Abstract |BACKGROUND: |
| |Cellulitis of the leg is a common bacterial infection of the skin and underlying tissue. We compared prophylactic low-dose |
| |penicillin with placebo for the prevention of recurrent cellulitis. |
| |METHODS: |
| |We conducted a double-blind, randomized, controlled trial involving patients with two or more episodes of cellulitis of the leg|
| |who were recruited in 28 hospitals in the United Kingdom and Ireland. Randomization was performed according to a |
| |computer-generated code, and study medications (penicillin [250 mg twice a day] or placebo for 12 months) were dispensed by a |
| |central pharmacy. The primary outcome was the time to a first recurrence. Participants were followed for up to 3 years. Because|
| |the risk of recurrence was not constant over the 3-year period, the primary hypothesis was tested during prophylaxis only. |
| |RESULTS: |
| |A total of 274 patients were recruited. Baseline characteristics were similar in the two groups. The median time to a first |
| |recurrence of cellulitis was 626 days in the penicillin group and 532 days in the placebo group. During the prophylaxis phase, |
| |30 of 136 participants in the penicillin group (22%) had a recurrence, as compared with 51 of 138 participants in the placebo |
| |group (37%) (hazard ratio, 0.55; 95% confidence interval [CI], 0.35 to 0.86; P=0.01), yielding a number needed to treat to |
| |prevent one recurrent cellulitis episode of 5 (95% CI, 4 to 9). During the no-intervention follow-up period, there was no |
| |difference between groups in the rate of a first recurrence (27% in both groups). Overall, participants in the penicillin group|
| |had fewer repeat episodes than those in the placebo group (119 vs. 164, P=0.02 for trend). There was no significant |
| |between-group difference in the number of participants with adverse events (37 in the penicillin group and 48 in the placebo |
| |group, P=0.50). |
| |CONCLUSIONS: |
| |In patients with recurrent cellulitis of the leg, penicillin was effective in preventing subsequent attacks during prophylaxis,|
| |but the protective effect diminished progressively once drug therapy was stopped. (Funded by Action Medical Research; PATCH I |
| |Controlled- number, ISRCTN34716921.). |
|17. Pending PURL Review | |
|Date | |
|sECTION 2: Critical Appraisal of Validity |
|[to be completed by the Potential PURL Reviewer] |
|[to be revised by the Pending PURL Reviewer if needed] |
|1. Number of patients starting each|136 Penicillin |
|arm of the study? |138 Placebo |
|2. Main characteristics of study |Inclusion: recurrent episode of cellulitis in past 24 weeks |
|patients (inclusions, exclusions, |Exclusion: doubt about diagnosis of cellulitis in past, use of abx for cellulitis prophylaxis in past 6 months, |
|demographics, settings, etc.)? |penicillin allergy, previous leg ulceration, surgery, or penetrating trauma, unwillingness of recruiting physician |
| |to randomly assign patients for medical reasons, age /= 33, >/= 3 previous episodes of cellulitis, presence of edema |
|8. What are the adverse effects of |Adverse events: 37 patients (PCN), 48 patients (placebo) |
|intervention compared with no |11 died, not due to meds (8 in PCN, 3 in placebo) |
|intervention? |Adverse events: death, nausea, diarrhea, vulvovaginitis, thrush, rash |
|9. Study addresses an appropriate | Well covered |
|and clearly focused question - |Adequately addressed |
|select one |Poorly addressed |
| |Not applicable |
| | |
| | |
| | |
| |Comments: Does penicillin prophylaxis decreased cellulitis recurrence |
|10. Random allocation to comparison| Well covered |
|groups |Adequately addressed |
| |Poorly addressed |
| |Not applicable |
| |Comments: Used Nottingham Clinical Trials Unit (NCTU) web-based randomization service |
|11. Concealed allocation to | Well covered |
|comparison groups |Adequately addressed |
| |Poorly addressed |
| |Not applicable |
| |Comments: Treatment assignments sent electronically to pharmacy, meds mailed to patients |
|12. Subjects and investigators kept| Well covered |
|“blind” to comparison group |Adequately addressed |
|allocation |Poorly addressed |
| |Not applicable |
| |Comments: |
|12. Comparison groups are similar | Well covered |
|at the start of the trial |Adequately addressed |
| |Poorly addressed |
| |Not applicable |
| |Comments: late 50s, mostly female, obese, Caucasian |
|14. Were there any differences | Well covered |
|between the groups/arms of the |Adequately addressed |
|study other than the intervention |Poorly addressed |
|under investigation? If yes, please|Not applicable |
|indicate whether the differences |Comments: Similar med compliance (78% placebo and 79% PCN reported taking at least 75% if the tablets) |
|are a potential source of bias. | |
|15. Were all relevant outcomes | Well covered |
|measured in a standardized, valid, |Adequately addressed |
|and reliable way? |Poorly addressed |
| |Not applicable |
| |Comments: telephone follow-up every 3 months for 12 months, then every 6 months thereafter to 36 months, assessed |
| |adverse events and use of health services |
|16. Are patient oriented outcomes |yes-time to and frequency of recurrence of cellulitis are patient oriented outcomes |
|included? If yes, what are they? | |
|17. What percent dropped out, and |5% (15 patients) withdrew consent or were lost to follow-up |
|were lost to follow up? Could this |4% (11 patients) died |
|bias the results? How? | |
|18. Was there an intention-to-treat|yes |
|analysis? If not, could this bias | |
|the results? How? | |
|19. If a multi-site study, are |not sure- doesn't breakdown results by site |
|results comparable for all sites? |Recruitment at 28 hospitals in UK and Ireland |
|20. Is the funding for the trial a |Supported by grant from Action Medical Research- not likely source of bias |
|potential source of bias? If yes, | |
|what measures were taken to insure | |
|scientific integrity? | |
|21. To which patients might the |Patients with recurrent cellulitis, tolerant of penicillin, in areas with low resistance to penicillin. |
|findings apply? Include patients in| |
|the study and other patients to | |
|whom the findings may be | |
|generalized. | |
|22. In what care settings might the|Outpatient and Inpatient, Nursing homes |
|findings apply, or not apply? | |
|23. To which clinicians or policy |Fam. Med, Derm, IM. ID |
|makers might the findings be | |
|relevant? | |
| |
|SECTION 3: Review of Secondary Literature |
|[to be completed by the Potential PURL Reviewer] |
|[to be revised by the Pending PURL Reviewer as needed] |
|Citation Instructions |For UpTo Date citations, use style modified from |
| |& AMA style. Always use Basow DS as editor & current year as publication year. |
| | |
| |EXAMPLE: Auth I. Title of article. {insert author name if given, & search terms or title.} In: Basow DS, ed. |
| |UpToDate [database online]. Waltham, Mass: UpToDate; 2009. Available at: . {Insert dated |
| |modified if given.} Accessed February 12, 2009. {whatever date PPRF reviewer did their search.} |
| | |
| |For DynaMed, use the following style: |
| |Depression: treatment {insert search terms or title}. In: DynaMed [database online]. Available at: |
| |. Last updated February 4, 2009. {Insert dated modified if given.} Accessed June 5,|
| |2009.{search date} |
|1. DynaMed excerpts | |
|2. DynaMed citation/access date |Title. Cellulitis Author. In: DynaMed [database online]. Available at: Last updated: |
| |5/15/13. Accessed 6/10/13 |
|3. Bottom line recommendation or summary |1st line prevention of recurrent cellulitis is emollients, compressive stockings. Can use PCN or erythromycin if |
|of evidence from DynaMed |other measures fail. |
|(1-2 sentences) | |
|4. UpToDate excerpts | |
|5. UpToDate citation/access date |Always use Basow DS as editor & current year as publication year. |
| |Title. Cellulitis and erysipelasAuthor. Larry M Baddour, MD, FIDSA In: UpToDate [database online]. Available|
| |at: . Last updated: 5/9/2013. Accessed6/10/13 |
|6. Bottom line recommendation or |Unclear efficacy of prophylactic antibiotics. Current options include penicillin (IM or PO), Clindamycin but for |
|summary of evidence from UpToDate |unclear duration. |
|(1-2 sentences) | |
|7. PEPID PCP excerpts | |
| | |
|username: fpinauthor | |
|pw: pepidpcp | |
|8. PEPID citation/access data |Author. Title. In: PEPID [database online]. Available at: . Last updated:. Accessed |
|9. PEPID content updating |1. Do you recommend that PEPID get updated on this topic? |
| |Yes, there is important evidence or recommendations that are missing |
| |No, this topic is current, accurate and up to date. |
| |If yes, which PEPID Topic, Title(s): |
| |2. Is there an EBM Inquiry (HelpDesk Answers and Clinical Inquiries) as indicated by the EB icon ([pic]) that |
| |should be updated on the basis of the review? |
| |Yes, there is important evidence or recommendations that are missing |
| |No, this topic is current, accurate and up to date. |
| |If yes, which Evidence Based Inquiry(HelpDesk Answer or Clinical Inquiry), Title(s): |
|10. Other excerpts (USPSTF; other | |
|guidelines; etc.) | |
|11. Citations for other excerpts | |
|12. Bottom line recommendation or | |
|summary of evidence from Other Sources| |
|(1-2 sentences) | |
|SECTION 4: Conclusions |
|[to be completed by the Potential PURL Reviewer] |
|[to be revised by the Pending PURL Reviewer as needed] |
|1. Validity: How well does the study |Give one number on a scale of 1 to 7 |
|minimize sources of internal bias and |(1=extremely well; 4=neutral; 7=extremely poorly) |
|maximize internal validity? |1 2 3 4 5 6 7 |
|2. If 4.1 was coded as 4, 5, 6, or 7, |Double-blinded RCT |
|please describe the potential bias and how | |
|it could affect the study results. | |
|Specifically, what is the likely direction | |
|in which potential sources of internal bias| |
|might affect the results? | |
|3. Relevance: Are the results of this study|Give one number on a scale of 1 to 7 |
|generalizable to and relevant to the health|(1=extremely well; 4=neutral; 7=extremely poorly) |
|care needs of patients cared for by “full |1 2 3 4 5 6 7 |
|scope” family physicians? | |
|4. If 4.3 was coded as 4, 5, 6, or 7, lease|Yes generalizable and relevant |
|provide an explanation. | |
|5. Practice changing potential: If the |Give one number on a scale of 1 to 7 |
|findings of the study are both valid and |(1=definitely a change from current practice; 4=uncertain; 7=definitely not a change from current practice) |
|relevant, does the practice that would be |1 2 3 4 5 6 7 |
|based on these findings represent a change | |
|from current practice? | |
|6. If 4.5 was coded as 1, 2, 3, or 4, |IDSA recommends penicillin, erythromycin for prophylaxis already |
|please describe the potential new practice | |
|recommendation. Please be specific about | |
|what should be done, the target patient | |
|population and the expected benefit. | |
|Applicability to a Family Medical Care |Give one number on a scale of 1 to 7 |
|Setting: |(1=definitely could be done in a medical care setting; 4=uncertain; 7=definitely could not be done in a |
|Is the change in practice recommendation |medical care setting) |
|something that could be done in a medical |1 2 3 4 5 6 7 |
|care setting by a family physician (office,| |
|hospital, nursing home, etc), such as a | |
|prescribing a medication, vitamin or herbal| |
|remedy; performing or ordering a diagnostic| |
|test; performing or referring for a | |
|procedure; advising, educating or | |
|counseling a patient; or creating a system | |
|for implementing an intervention? | |
|8. If you coded 4.7 as a 4, 5, 6 or 7, |Penicillin is cheap, accessible. |
|please explain. | |
|9. Immediacy of Implementation: Are there |Give one number on a scale of 1 to 7 |
|major barriers to immediate implementation?|(1=definitely could be immediately applied; 4=uncertain; 7=definitely could not be immediately applied) |
|Would the cost or the potential for |1 2 3 4 5 6 7 |
|reimbursement prohibit implementation in | |
|most family medicine practices? Are there | |
|regulatory issues that prohibit | |
|implementation? Is the service, device, | |
|drug or other essentials available on the | |
|market? | |
|10. If you coded 4.9 as 4, 5, 6, or 7, | |
|please explain why. | |
|11. Clinical meaningful outcomes or patient|Give one number on a scale of 1 to 7 |
|oriented outcomes: Are the outcomes |(1=definitely clinically meaningful or patient oriented; 4=uncertain; 7=definitely not clinically meaningful |
|measured in the study clinically meaningful|or patient oriented) |
|or patient oriented? |1 2 3 4 5 6 7 |
|12. If you coded 4.11 as a 4, 5, 6, or 7 |Still unclear how long to continue prophylaxis, differences in recurrence rates decreased once prophylaxis |
|please explain why. |was discontinued. |
|13. In your opinion, is this a Pending |Give one number on a scale of 1 to 7 |
|PURL? |(1=definitely a Pending PURL; 4=uncertain; 7=definitely not a Pending PURL) |
|Criteria for a Pending PURL: |1 2 3 4 5 6 7 |
|Valid: Strong internal scientific validity;| |
|the findings appears to be true. | |
|Relevant: Relevant to the practice of | |
|family medicine | |
|Practice changing: There is a specific | |
|identifiable new practice recommendation | |
|that is applicable to what family | |
|physicians do in medical care settings and | |
|seems different than current practice. | |
|Applicability in medical setting: | |
|Immediacy of implementation | |
|14. Comments on your response in 4.13 |Clinical meaningfulness still unclear, given unclear what's best in terms of duration of prophylactic |
| |medications and unsure if this is a practice change since current recommendations include prophylactic abx. |
|SECTION 4.1: Diving for PURLs |
|[optional for the potential PURL reviewer -if you wish to be the author on the summary] |
|1. Study Summary- Please summarize the |This double-blind randomized controlled trial of 274 patients compared penicillin to placebo in prevention of|
|study in 5-7 sentences |recurrent leg cellulitis. Patients received either Penicillin 250 mg PO BID or placebo for 12 months |
| |(prophylaxis phase). Adverse events, use of health services, and recurrence of cellulitis were assessed by |
| |telephone calls at 3-month intervals during the prophylaxis phase and every 6 months during the follow-up |
| |phase (13-36 months). |
| |Primary outcome measure was time from randomization to recurrence of cellulitis. Secondary outcome measures |
| |include proportions of participants with recurrent cellulitis and with new edema or ulceration, adverse |
| |events, length of hospital stay for recurrent cellulitis, and cost-effectiveness. |
| |Median time to recurrent cellulitis was 626 days (penicillin) and 532 days (placebo). During the prophylaxis |
| |phase, there was a 45% risk reduction of recurrent cellulitis in patients who received penicillin (hazard |
| |ratio 0.55, CI 0.35-0.86, p=0.01). Significant risk reduction was not sustained in follow-up phase and there |
| |was no significant difference in adverse events between the 2 groups. |
|Criteria- note yes or no for those which |RELEVENT - Yes |
|this study meets |VALID - Yes |
| |CHANGE IN PRACTICE- No |
| |MEDICAL CARE SETTING - Yes |
| |IMMEDIATELY APPLICABLE - Yes |
| |CLINICALLY MEANINGFUL - Yes |
|3. Bottom Line- one –two sentences noting |Low-dose penicillin can be used to lengthen time to recurrence and decrease the frequency of repeat episodes |
|the bottom line recommendation |of cellulitis. However, it is still uncertain what length of time is best for prophlyactic penicillin use. |
|4. Title Proposal |Penicillin for the prevention of recurrent cellulitis. |
|SECTION 5: Editorial Decisions |
|[to be completed by the FPIN PURLs Editor or Deputy Editor] |
|1. FPIN PURLs editorial decision |1 Pending PURL Review—Schedule for Review |
|(select one) |2 Pending PURL—Forward to JFP Editor |
| |3 Drop |
|Follow up issues for Pending PURL Reviewer | |
|3. FPIN PURLS Editor making decision |1 Bernard Ewigman |
| |2 Sarah-Anne Schumann |
| |3 John Hickner |
| |4 Kate Rowland |
|4. Date of decision | |
|5. Brief summary of decision | |
|SECTION 6: Survey Questions for SERMO, PURLs Instant Polls and Other Surveys |
|[To be completed by the PURLs Survey Coordinator and PURLs Editor] |
|1. Current Practice Question for Surveys | |
|2. Barriers to Implementation Question for| |
|Surveys | |
|3. Likelihood of Change Question for | |
|Surveys | |
|4. Other Questions for Surveys | |
|SECTION 7: Variables for Secondary Database Analyses |
|1. Population: Age, gender, race, ethnicity | |
|2. Diagnoses | |
|3. Drugs or procedures | |
|SECTION 8: Pending PURL Review Assignment |
|[to be completed by PURLs Project Manager |
|1. Person Assigned for | |
|Pending PURL Review | |
|2. Date Pending PURL Review is due | |
|SECTION 9: Pending PURL Review |
|[to be completed by the Pending PURL Reviewer] |
|1. Did you address the follow up issues | Yes |
|identified at the PURL Jam (Section 5.2). |No |
|Add comments as needed. |Not applicable |
| |Comments: |
|2. Did you review the Sermo poll & Instant | Yes |
|Poll results (if available)? Add comments |No |
|as needed. |Not applicable |
| |Comments: |
|3. Did you modify Sections 2, 3, or 4? Add| Yes |
|comments as needed. |No |
| |Not applicable |
| |Comments: |
|SECTION 10: PURL Authoring Template |
|[to be completed by the assigned PURL Author] |
|Author Citation Information (Name, Degrees, Affiliation) | |
|1. Practice Changer | |
|2. Illustrative Case | |
|3. Background/ | |
|Clinical Context/Introduction/Current Practice/ | |
|4. Study Summary | |
|5. What’s New | |
|6. Caveats | |
|7. Challenges to Implementation | |
|8. Acknowledgment Sentence |The PURLs Surveillance System is supported in part by Grant Number UL1RR024999 |
| |from the National Center For Research Resources, a Clinical Translational Science |
| |Award to the University of Chicago. The content is solely the responsibility of |
| |the authors and does not necessarily represent the official views of the National |
| |Center For Research Resources or the National Institutes of Health. |
| | |
| |If using UHC data: |
| |We acknowledge Sofia Medvedev of University HealthSystem Consortium (UHC) in Oak |
| |Brook, IL for analysis of the National Ambulatory Medical Care Survey data. |
|9. References | |
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