Table 3.
Treatment outcomes of fluoroquinolone (FQ)-containing regimens for pulmonary tuberculosis (TB)
| FQ | (mg) | Treatment regimenA | Study | Treatment outcome | Refs. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FQ (months) | Control (months) | Type | No.C | Patient | Primary endpoint(s) | End-pointD | End-point FQC | End-point controlC | FQ minus controlC,E | FQ non-inferiorB | ||||
| G | 400 | S |
GHRZ (2) GHR (2) |
HRZE (2) HR (4) |
Non-inferiority, open-label, RCT | 1356 | R-sensitive, smear-positive | Unfavourable outcome (culture-positive at the end of treatment, relapse or re-infection, or death, or study drop-out) | 24 | 21% | 17% | 3.5 (− 0.7 to 7.7) %F | No | [16] |
| G | 400 | S |
GHRZ (2)G GHR (2)G |
HRZE (2)G HR (4)G |
Open-label, RCT | 136 (G)H 165 (C)H |
Culture-positive | Unfavourable outcome (culture-positive, or death, or clinical need to change treatment) recurrence |
0 24 |
5%I 16%I,J |
3%I 6%I |
– | N/a | [17] |
| L M |
750 400 |
LB (3 +)K MB (3 +)K |
– | Open-label, RCT | 77 (L)L 74 (M)L |
MDR, culture-positive | Treatment success (sum of cure and completion)M treatment failure (sum of death and failure) |
0 0 |
84% (L) 80% (M) 8% (L) 7% (M) |
– | M-L: − 4.7 (− 17.0 to 7.6) % M-L: − 1.0 (− 10.1 to 8.1) % |
N/a | [15] | |
| M | 400 | S |
MHRZ (2)G MHR (2)G |
HRZE (2)G HR (4)G |
Open-label, RCT | 115 (M)H 165 (C)H |
Culture-positive | Unfavourable outcome (culture-positive, or death, or clinical need to change treatment) recurrence |
0 24 |
2%I 10%I |
3%I 6%I |
– | N/a | [17] |
B background regimen according to WHO guidelines, C control, E ethambutol, FQ fluoroquinolone, G gatifloxacin, H isoniazid, L levofloxacin, M moxifloxacin, MDR multi-drug resistance, O ofloxacin, RCT randomized controlled trial, R rifampicin, S short-course, Z pyrazinamide
ADaily regimen unless indicated otherwise
B(Modified) intention-to-treat and per-protocol population unless indicated otherwise
C(Modified) intention-to-treat population unless indicated otherwise
DMonths after the end of treatment
EPoint-difference (95% CI)
FSubgroups HIV-negative, cavitation, BMI ≥ 16: 95% CI in favour of Control
GThrice-weekly
HPremature termination due to the extent of TB recurrence in the G- and M-arm
IDrug-susceptible (DS) TB patients (tested drugs: H,R,E,O): 94% (G), 97% (M) and 84% (C): DS-TB patients: equivalent frequencies for primary endpoints compared to the total group
JFQ vs. control: p < 0.05
K3 months’ trial medication, thereafter according to WHO guidelines
LPremature termination due to drop of patient enrollment
MFollow-up analysis comparing all WHO definitions of treatment outcome. Initial study had primary outcome = sputum culture conversion