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. 2016 Dec 23;48(2):198–207. doi: 10.1016/j.bjm.2016.12.003

Table 1.

Characteristics of randomized clinical trials, comparing FDC with SD regimens for treatment of TB, that were included in the systematic review.

Study No. of patients Setting Follow-up (mo) Eligibility criteria Study treatments, initial phase (2 mo)a Jadad scale
Su, 200214 105 Taiwan 6 18+ yr with active pulmonary TB confirmed by smear or culture and no history of previous treatment for TB FDC = INH 50 mg + RIF 120 mg + PZA 250 mg + EMB 1200 mg; SD = INH 300 mg + RIF 450 mg + PZA 150 mg + EMB 120 mg 2
Gravendeel et al., 200323 360 Indonesia 36 Sputum positive, weight of 33–50 kg, and provided written consent for participation FDC = INH 75 mg + RIF 150 mg + PZA 400 mg + EMB 275 mg; SD = INH 300 mg + RIF 450 mg + PZA 500 mg + EMB 250 mg 2
Zaka et al., 200825 293 Pakistan 6 15–55 yr, sputum positive, no kidney, liver or heart disease, and not pregnant Group A (FDC) = INH 75 mg + RIF 120 mg + PZA 350 mg + EMB 250 mg; Group B (FDC) = INH 60 mg + RIF 120 mg + PZA 300 mg + EMB 225 mg; Group C (SD) = INH 100 mg + RMP 450 mg and 150 mg + PZA 500 mg 3
Bartacek et al., 200922 1159 Egypt, India, Pakistan, Philippines, and Thailand 21 15+ yr, ≥2 positive sputum samples or 1 positive sputum sample and a chest X-ray, and received treatment for TB for ≤1 mo FDC = INH 75 mg + RIF 150 mg + PZA 400 mg + EMB 275 mg; SD = INH 75 mg + RIF 150 mg + PZA 400 mg + EMB 275 mg 3
Lienhardt et al., 201124 1585 Africa, Asia, and Latin America 30 New diagnosis of TB confirmed by sputum smear-positive, received treatment for TB for ≤4 wk, fixed address, agreed to receive visitors, and provided written informed consent FDC = INH 75 mg + RIF 150 mg + PZA 400 mg + EMB 275 mg; SD = INH 100 mg + RIF 150 mg + PZA 400 mg + EMB 400 mg 3

EMB, ethambutol; FDC, fixed-dose combination; INH, isoniazid; PZA, pirazinomide; RIF, rifampin; SD, single dose; TB, tuberculosis.

a

Doses were administered on the basis of body weight according to WHO and The European Union recommendations.