Adverse Reactions to Vancomycin Used as Prophylaxis for CSF Shunt Procedures

Odio, Carla; Mohs, Edgar; Sklar, Fred H.; Nelson, John D.; McCracken, George H.

doi:10.1001/archpedi.1984.02140390009004

Cited by 47 publications

(36 citation statements)

References 16 publications

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“…In contrast, after the 0.5-g dosage (60 min), only two volunteers developed red man's syndrome. This is a higher incidence than has been described in patients (7,20). However, our data are in good agreement with recently reported data for healthy volunteers (10).…”

Section: Discussionsupporting

confidence: 93%

Pharmacokinetics and serum bactericidal activity of vancomycin alone and in combination with ceftazidime in healthy volunteers

Boeckh

Lode

Börner

et al. 1988

Antimicrob Agents Chemother

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The pharmacokinetics and serum bactericidal activity of vancomycin alone and in combination with ceftazidime were investigated in 10 healthy volunteers. The pharmacokinetic parameters showed no significant differences (P less than 0.05) between single and combined administration. No antagonistic effects were observed in serum bactericidal activity with the combination against 20 gram-positive and 20 gram-negative locally isolated bacteria. A titer of greater than or equal to 1:8 was generated by the combination against all test strains except enterococci. Seven of ten volunteers developed a typical "red man's syndrome" during the administration of 1.0 g of vancomycin.

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Section: Discussionsupporting

confidence: 93%

Pharmacokinetics and serum bactericidal activity of vancomycin alone and in combination with ceftazidime in healthy volunteers

Boeckh

Lode

Börner

et al. 1988

Antimicrob Agents Chemother

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“…The most common adverse effect of intravenously administered vancomycin is "red man syndrome" which is characterized by erythema, pruritus, and in severe cases angioedema and cardiovascular complications (1,3,8,10,11,15). We have previously shown that vancomycin-induced red man syndrome is associated with histamine release (13).…”

mentioning

confidence: 99%

Comparison of vancomycin- and teicoplanin-induced histamine release and "red man syndrome"

Sahai

Healy

Shelton

et al. 1990

Antimicrob Agents Chemother

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Twelve healthy adult males participated in a double-blind, randomized, two-way crossover study to determine histamine release and the frequency and severity of "red man syndrome" (RMS) following intravenous administration of vancomycin (15 mg/kg of body weight over 60 min) and teicoplanin (15 Vancomycin is widely used for the treatment of infections caused by gram-positive organisms. The most common adverse effect of intravenously administered vancomycin is "red man syndrome" which is characterized by erythema, pruritus, and in severe cases angioedema and cardiovascular complications (1,3,8,10,11,15). We have previously shown that vancomycin-induced red man syndrome is associated with histamine release (13).Teicoplanin is an investigational glycopeptide antibiotic similar in structure and spectrum of activity to vancomycin and is currently under study for the treatment and prophylaxis of infections due to gram-positive organisms (17, 18). There have been two anecdotal reports of teicoplanininduced red man syndrome (B. Fant, personal communication); however, the frequency and severity of this reaction have not been systematically studied. The purpose of this investigation was to compare histamine release and the incidence and severity of red man syndrome following intravenous administration of vancomycin and teicoplanin to healthy adult volunteers. MATERIALS AND METHODSThis study was approved by the Committee on the Conduct of Human Research, Medical College of Virginia Hospitals, and written informed consent was obtained from the participants. Subjects were admitted to the Biopharmaceutics Research Center, School of Pharmacy, Medical College of Virginia, on the morning of each study day.Volunteers. Twelve healthy adult, Caucasian, male volunteers participated in a double-blind, randomized, two-way crossover study. There was a 2-week washout period between treatments. The mean ± standard deviation age and * Corresponding author. weight were 24.1 + 1.2 years and 76.9 + 5.5 kg, respectively. Exclusion criteria for subjects were previous exposure to vancomycin and/or teicoplanin, smoking, total body weight more than 10% above or below ideal weight, known hypersensitivity to any drug, chronic illnesses, atopy, laboratory abnormalities on entry into the study, requirements for any medication, and use of antihistamine-containing products within 7 days prior to entering the study. Subjects were instructed to avoid all medications throughout the study period. No subject ingested alcohol or caffeine 48 h prior to each study day, and subjects fasted overnight and for 3 h after administration of each antibiotic.Drug administration and sample collection. All antibiotic doses were prepared by the same investigator (D.P.H.

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“…11,18,27 The trial by Blum et al 11 showed no difference in the infection rate with a relatively small number of patients. The treatment group consisted of 50 patients who received preoperative cefazedone (50 mg/kg at the time of induction).…”

Section: Resultsmentioning

confidence: 99%

“…12,43 Therefore, 9 articles satisfied inclusion criteria for this systematic review and meta-analysis (Table 1). 1,11,18,20,26,27,30,39,40 …”

Section: Search Resultsmentioning

confidence: 99%

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Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 6: Preoperative antibiotics for shunt surgery in children with hydrocephalus: a systematic review and meta-analysis

Klimo

Poppel

Thompson

et al. 2014

PED

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Object The objective of this systematic review and meta-analysis was twofold: to answer the question “What is the evidence for the effectiveness of prophylactic intravenous antibiotics for infection prevention in shunt surgery?” and to make treatment recommendations based on the available evidence. Methods The US National Library of Medicine PubMed/MEDLINE database and the Cochrane Database of Systematic Reviews were queried using MeSH headings and key words relevant to prophylactic antibiotic use in children undergoing a shunt operation. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). A meta-analysis was conducted using a random-effects model to calculate a cumulative estimate of treatment effect using risk ratio (RR). Heterogeneity was assessed using chi-square and I2 statistics. A sensitivity analysis was also conducted. Based on the quality of the literature and the result of the meta-analysis, a recommendation was rendered (Level I, II, or III). Results Nine studies (4 Class I, 3 Class II, and 2 Class III) met our inclusion criteria. Of 7 randomized controlled trials (RCTs), 3 were downgraded from Class I to Class II because of significant quality issues, and all RCTs were potentially underpowered. In only 2 Class in retrospective cohort studies were preoperative antibiotic agents found to be protective against shunt infection. When data from the individual studies were pooled together, the infection rate in the prophylactic antibiotics group was 5.9% compared with 10.7% in the control group. Using a random-effects model, the cumulative RR was 0.55 (95% CI 0.38–0.81), indicating a protective benefit of prophylactic preoperative intravenous antibiotics. A sensitivity analysis of RCTs only (n = 7) also demonstrated a statistical benefit, but an analysis of higher-quality RCTs only (n = 4) did not. Conclusions Within the limits of this systematic review and meta-analysis, administration of preoperative antibiotic agents for shunt surgery in children was found to lower the infection risk (quality of evidence: Class II; strength of recommendation, Level II). Recommendation The use of preoperative antibiotic agents can be recommended to prevent shunt infection in patients with hydrocephalus. It was only by combining the results of the various underpowered studies (meta-analysis) that the use of preoperative antibiotics for shunt surgery in children was shown to lower the risk of shunt infection. Strength of Recommendation: Level II, moderate degree of clinical certainty.

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Adverse Reactions to Vancomycin Used as Prophylaxis for CSF Shunt Procedures

Cited by 47 publications

References 16 publications

Pharmacokinetics and serum bactericidal activity of vancomycin alone and in combination with ceftazidime in healthy volunteers

Pharmacokinetics and serum bactericidal activity of vancomycin alone and in combination with ceftazidime in healthy volunteers

Comparison of vancomycin- and teicoplanin-induced histamine release and "red man syndrome"

Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 6: Preoperative antibiotics for shunt surgery in children with hydrocephalus: a systematic review and meta-analysis

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