Richard J. O'Brien

USPHS Tuberculosis Short-Course Chemotherapy Trial 21: Effectiveness, Toxicity, and Acceptability: The Report of Final Results

STUDY OBJECTIVE To determine the effectiveness, toxicity, and acceptability of a 6-month antituberculous regimen compared with a 9-month regimen. DESIGN A nonblinded, unbalanced, randomized, multicenter clinical trial. SETTING Twenty-two tuberculosis clinics in public health departments and hospitals in the United States. PATIENTS Patients were eligible if Mycobacterium tuberculosis, isolated from sputum cultures, was susceptible to study drugs. Of 1451 patients enrolled, 75% (617 of 823) assigned to the 6-month regimen and 71% (445 of 628) assigned to the 9-month regimen were eligible. INTERVENTIONS Patients took self-administered isoniazid and rifampin daily for 24 weeks (6-month regimen) or 36 weeks (9-month regimen). In addition, patients assigned to the 6-month regimen took self-administered pyrazinamide daily during the first 8 weeks. RESULTS Patients on the 6-month regimen converted more rapidly than patients on the 9-month regimen (94.6% compared with 89.9% after 16 weeks of therapy, with a difference of 4.7% [95% CI, 0.7% to 8.7%]); had similar rates of adverse drug reactions (7.7% compared with 6.4%, with a difference of 1.3% [95% CI, 0.0% to 4.6%]); had lower noncompliance rates (16.8% compared with 29.2%, with a difference of 12.4% [95% CI, 6.8% to 18.0%]); and had similar relapse rates 96 weeks after completing therapy (3.5% compared with 2.8%, with a difference of 0.7% [95% CI, 0.0% to 3.9%]). A significantly greater proportion of patients assigned to the 6-month regimen successfully completed therapy (61.4% compared with 50.6%; chi 2 = 11.976). CONCLUSIONS Our results suggest that this 6-month regimen is similar in effectiveness, toxicity, and acceptability to the 9-month regimen for treating pulmonary tuberculosis.

Discriminators between Hantavirus-Infected and -Uninfected Persons Enrolled in a Trial of Intravenous Ribavirin for Presumptive Hantavirus Pulmonary Syndrome

To provide a potentially therapeutic intervention and to collect clinical and laboratory data during an outbreak of hantavirus pulmonary syndrome (HPS), 140 patients from the United States with suspected HPS were enrolled for investigational intravenous ribavirin treatment. HPS was subsequently laboratory confirmed in 30 persons and not confirmed in 105 persons with adequate specimens. Patients with HPS were significantly more likely than were hantavirus-negative patients to report myalgias from onset of symptoms through hospitalization, nausea at outpatient presentation, and diarrhea and nausea at the time of hospitalization; they were significantly less likely to report respiratory symptoms early in the illness. The groups did not differ with regard to time from the onset of illness to the point at which they sought care; time from onset, hospitalization, or enrollment to death was significantly shorter for patients with HPS. At the time of hospitalization, patients with HPS more commonly had myelocytes, metamyelocytes, or promyelocytes on a peripheral blood smear, and significantly more of them had thrombocytopenia, hemoconcentration, and hypocapnia. Patterns of clinical symptoms, the pace of clinical evolution, and specific clinical laboratory parameters discriminated between these 2 groups.

Usefulness of skin testing with mycobacterial antigens in children with cervical lymphadenopathy.

One hundred twenty-three children with chronic cervical lymphadenopathy were skin-tested with purified protein derivative (PPD)-B (Mycobacterium intracellulare, PPD-Y (Mycobacterium kansasii), PPD-G (Mycobacterium serofulaceum) (nontuberculous mycobacterial antigens (NTMags) and PPD-T (Mycobacterium tuberculosis). Children with culture-confirmed mycobacterial disease had significantly larger reactions to NTMages and were 6 times more likely to have PPD-B responses of 10 mm than those with negative microscopy/culture results. Children with acid-fast bacilli present in clinical specimens but with negative culture results were 3 times more likely to have 10 mm induration to PPD-B than those with negative microscopy/culture results. In all groups except those with culture-confirmed M. tuberculosis, responses to PPD-T were significantly smaller than those to the NTMags. We conclude that NTMags, particularly PPD-B, may be useful in diagnosing childhood mycobacterial cervical adenopathy; however, their usefulness in distinguishing disease caused by M. tuberculosis from that resulting from other my-cobacteria is unknown.