Transmission of hepatitis C in a pharmacologic study.

OBJECTIVE

To describe an outbreak of hepatitis C in a clinical research study.

DESIGN

Observational study.

SETTING

Tertiary-care hospital.

PATIENTS: Healthcare workers who volunteered to be subjects in a study of the metabolic effects of inhaled and oral corticosteroids who were unwittingly exposed to hepatitis C virus (HCV).

METHODS

Epidemiological investigation and serological analyses.

RESULTS

One chronic carrier of HCV was identified. Four fellow workers volunteering in the studies became infected with HCV, with 96% homology among strains. There was no evidence of spread from infected healthcare workers to patients on whom they had performed arterial punctures (2 of 214 positive, unrelated to each other and to the outbreak strain).

CONCLUSION

Infection control standards in clinical research must be maintained vigorously to prevent transmission of blood-borne pathogens such as HCV.