Clostridioides difficile Module 2 Evidence-tabel

Evidence table for intervention studies (randomized controlled trials and non-randomized observational studies [cohort studies, case-control studies, case series])

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Follow-up

Outcome measures and effect size

Comments

Jabbar, 2010

Type of study: prospective cohort

Setting and country: volunteers, hospital, US

Funding and conflicts of interest: The study was funded by The US Department of Veterans Affairs Research Service.
Two authors report receiving commercial funds.

Inclusion criteria: ten healthy volunteers, all of them nonclinical research personnel at Hines VA Hospital

Exclusion criteria: not applicable

N total at baseline: 10

Important prognostic factors: 2/10 had preinoculation hand cultures positive for C. difficile, although the number of colonies was negligible (fewer than 3 CFU per plate).

Describe intervention: hand washing using alcohol-based hand rub compared to Chlorhexidine hand wash

Length of follow-up: no follow-up

Loss-to-follow-up: not applicable

Incomplete outcome data: not applicable

Outcome measures:

Washing with gluconate soap–and-water:
Mean log10 reduction 0.90 + 0.37 CFU/cm²

Washing with Isagel:
mean log10 reduction of 0.11 + 0.20 CFU/cm²

Washing with Endure:
mean log10 reduction 0.37 + 0.42 CFU/cm²

Washing with Purell:
mean log10 reduction 0.14 + 0.33 CFU/cm²

Transmission:
mean efficiency of transfer of 30.2% + 17.4%.after ABHR use

The authors conclude that hand washing with soap and water is significantly more effective at removing C. difficile spores from the hands of volunteers than are ABHRs. Residual spores are readily transferred by a handshake after use of ABHR.

Knight, 2010

Type of study: retrospective chart review

Setting and country: patients with CDAD, hospital, US

Funding and conflicts of interest: authors declare no conflicts of interest.

Inclusion criteria: adult (age ≥18 years) patients with CDAD and in-patient status at our institution between January 1, 2001, and June 30, 2008

Exclusion criteria: not fulfilling inclusion criteria

N total at baseline: 766

Important prognostic factors: 270 cases of CDAD were identified before ABHR implementation, and 496 cases were identified after implementation

Describe intervention: implementation of AHBR Alcohol based hand rub (Alcohol based hand rub ) policy

Length of follow-up: 7,5 years

Loss-to-follow-up: not applicable

Incomplete outcome data: not applicable

Outcome measures:

Incidence rate prior to ABHR implementation:
4.96 per 10,000 patient-days

Incidence rate prior to ABHR implementation:
3.98 per 10,000 patient-days (P = 0.0036).

Compliance:
compliance rose from 46% to 90%.

The authors conclude that the data provides no evidence of an increased CDAD rate after implementation of an ABHR policy at our institution.

Kundrapu, 2014

Type of study: prospective cohort study

Setting and country: patients, hospital, US

Funding and conflicts of interest: study was supported by the Department of Veterans Affairs. All authors declare no conflict of interest.

Inclusion criteria: adult (age ≥18 years) patients with CDI Clostridioides difficile-infectie (Clostridioides difficile-infectie ) or asymptomatic carriers of toxigenic C. difficile identified through rectal surveillance cultures

Exclusion criteria: not fulfilling inclusion criteria

N total at baseline: 44 patients 121 hands

Important prognostic factors: 28 patients with CDI, 16 asymptomatic carriers

Describe intervention: hand hygiene using alcohol hand rub (Purell) or soap and water hand wash with soap containing 0.5% triclosan

Length of follow-up: not applicable

Loss-to-follow-up: not applicable

Incomplete outcome data: not applicable

Outcome measures:
Positive culture after hand wash 6/30 (20%)
Positive culture after alcohol rub 28/30 (93%)
RR = 0.21 (95% CI 0.10 to 0.44) in favour of hand washing

The authors conclude that the hand washing was effective for reducing levels of C. difficile spores on hands.

Oughton, 2010

Type of study: prospective randomized cross-over study

Setting and country: patients, hospital, Canada

Funding and conflicts of interest: Study was supported by the Canadian Institutes of Health Research and Bayer Healthcare (Canada). All authors declare no conflict of interest.

Inclusion criteria: ten hospital laboratory workers volunteered for this study

Exclusion criteria: not fulfilling inclusion criteria

N total at baseline: 10 patients

Important prognostic factors: 120 observations whole-hand protocol, 318 observations palmar surface protocol

Describe intervention: The hand hygiene interventions studied were (1) warm (30 C) water with plain soap (Hygenipak Instafoam, Deb Canada), (2) cold (15 C) water with plain soap (Hygenipak Instafoam, Deb Canada), (3) warm (30 C) water with 2% chlorhexidine antibacterial soap (Hygenipak 2% CHG foaming skin cleanser, Deb Canada), (4) antiseptic hand wipes with 40% vol/vol ethanol and 0.5% parachlorometaxylenol (Sani-dex antimicrobial hand wipes, PDI), (5) alcohol-based handrub with 70% vol/vol isopropanol (Manorapid, Antiseptica, Pulheim-Brauwiler), and (6) a no-wash negative control.

Length of follow-up: not applicable

Loss-to-follow-up: not applicable

Incomplete outcome data: not applicable

Outcome measures:

water and plain soap compared to alcohol-based handrub
mean log10 reduction of 2.08 CFU/mL (95% CI 1.69 to 2.47)

Cold water and plain soap compared to alcohol-based handrub
mean log10 reduction of l1.46 CFU/mL (95% CI 1.06 to 1.85)

The authors conclude that handwashing with soap and water showed the greatest efficacy in removing C. difficile and should be performed preferentially over the use of alcohol-based handrubs when contact with C. difficile is suspected or likely.