Fluoroquinolones for treating tuberculosis

Lilia E Ziganshina; Stephen B Squire

doi:10.1002/14651858.CD004795.pub3

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Analysis 1.1

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 1 Cure (sputum culture conversion) at 8 weeks.

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Analysis 1.2

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 2 Treatment failure at 12 months.

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Analysis 1.3

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 3 Relapse.

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Analysis 1.4

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 4 Relapse: by HIV status.

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Analysis 1.5

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 5 Time to sputum culture conversion (months).

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Analysis 1.6

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 6 Time to sputum culture conversion (months): by HIV status.

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Analysis 1.7

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 7 Clinical or radiological improvement at 8 weeks.

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Analysis 1.8

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 8 Serious adverse events.

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Analysis 1.9

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 9 Total number of adverse events.

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Analysis 1.10

Comparison 1 Fluoroquinolone substituted into regimen, Outcome 10 Total number of adverse events, substitutions for ethambutol.

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Analysis 2.1

Comparison 2 Fluoroquinolone added to regimen, Outcome 1 Cure (sputum culture conversion) at 8 weeks.

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Analysis 2.2

Comparison 2 Fluoroquinolone added to regimen, Outcome 2 Treatment failure at 12 months.

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Analysis 2.3

Comparison 2 Fluoroquinolone added to regimen, Outcome 3 Clinical or radiological improvement at 8 weeks.

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Analysis 2.4

Comparison 2 Fluoroquinolone added to regimen, Outcome 4 Death from any cause.

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Analysis 2.5

Comparison 2 Fluoroquinolone added to regimen, Outcome 5 Tuberculosis‐related death.

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Analysis 2.6

Comparison 2 Fluoroquinolone added to regimen, Outcome 6 Serious adverse events.

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Analysis 3.1

Comparison 3 Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen, Outcome 1 Cure (sputum culture conversion) within 2 to 3 weeks.

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Analysis 3.2

Comparison 3 Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen, Outcome 2 Treatment failure at 12 months.

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Analysis 3.3

Comparison 3 Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen, Outcome 3 Clinical or radiological improvement at 8 weeks.

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Analysis 3.4

Comparison 3 Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen, Outcome 4 Total number of adverse events.

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Analysis 4.1

Comparison 4 Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens, Outcome 1 Cure (sputum culture conversion within 2 to 3 weeks).

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Analysis 4.2

Comparison 4 Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens, Outcome 2 Treatment failure at 12 months.

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Analysis 4.3

Comparison 4 Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens, Outcome 3 Clinical or radiological improvement at 8 weeks.

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Analysis 4.4

Comparison 4 Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens, Outcome 4 Total number of adverse events.

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Table 1. Highest multiple‐drug‐resistant tuberculosis (MDR‐TB) rates in 1998a

Location	New case	Previously treated case
Estonia	14.1	18.1
Henan Province, China	10.8	15.1
Latvia	9.0	12.0
Ivanovo Oblast, Russian Federation	9.0	12.3
Tomsk Oblast, Russian Federation	6.5	13.7
^aSource: Loddenkemper 2002.

Table 1. Highest multiple‐drug‐resistant tuberculosis (MDR‐TB) rates in 1998a

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Table 2. Risk of bias assessment

Trial	Allocation sequence generation	Allocation concealment	Blinding	Inclusion^a
Burman 2006	Unclear	Unclear	Unclear	Inadequate
El‐Sadr 1998	Adequate	Unclear	Assessors only	Adequate for 8 weeks Inadequate for continuation phase (39% lost)
Huang 2000	Unclear	Unclear	Unclear	Adequate
Ji 2001	Unclear	Unclear	Unclear	Adequate
Kennedy 1993	Unclear	Unclear	None	Adequate
Kennedy 1996	Adequate	Adequate	Assessors only	Adequate
Kohno 1992	Unclear	Unclear	Unclear	Inadequate
Lu 2000	Adequate	Unclear	Participants: yes Providers and assessors: unclear	Adequate
Mohanty 1993	Unclear	Unclear	Providers, participants, and radiograph assessors: yes	Inadequate
Saigal 2001	Adequate	Unclear	None	Adequate
Sun 2000	Unclear	Unclear	Unclear	Adequate
^aInclusion of all randomized participants in the final analysis.

Table 2. Risk of bias assessment

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Comparison 1. Fluoroquinolone substituted into regimen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cure (sputum culture conversion) at 8 weeks Show forest plot	3	416	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.82, 1.17]

1.1 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.88, 1.32]
1.2 Ciprofloxacin vs ethambutol plus pyrazinamide	1	20	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.42, 1.09]
1.3 Moxifloxacin vs ethambutol	1	336	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.83, 1.19]
2 Treatment failure at 12 months Show forest plot	3	388	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [0.71, 6.42]

2.1 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.13, 70.83]
2.2 Ciprofloxacin vs ethambutol plus pyrazinamide	2	328	Risk Ratio (M‐H, Fixed, 95% CI)	2.03 [0.63, 6.58]
3 Relapse Show forest plot	3	384	Risk Ratio (M‐H, Fixed, 95% CI)	7.17 [1.33, 38.58]

3.1 Ciprofloxacin vs ethambutol plus pyrazinamide	1	168	Risk Ratio (M‐H, Fixed, 95% CI)	15.72 [0.91, 270.96]
3.2 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.33, 27.23]
3.3 Ofloxacin vs ethambutol	1	156	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Relapse: by HIV status Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 HIV‐positive participants: ciprofloxacin vs ethambutol plus pyrazinamide	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 HIV‐negative participants: ciprofloxacin vs ethambutol plus pyrazinamide	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Time to sputum culture conversion (months) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5.1 Ciprofloxacin vs ethambutol plus pyrazinamide	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Time to sputum culture conversion (months): by HIV status Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

6.1 HIV‐positive participants: ciprofloxacin vs ethambutol plus pyrazinamide	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
6.2 HIV‐negative participants: ciprofloxacin vs ethambutol plus pyrazinamide	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
7 Clinical or radiological improvement at 8 weeks Show forest plot	2	216	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.49, 1.59]

7.1 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.88, 1.32]
7.2 Ofloxacin vs ethambutol	1	156	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.44, 1.08]
8 Serious adverse events Show forest plot	5	743	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.56, 1.72]

8.1 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 15.26]
8.2 Ofloxacin vs ethambutol	1	156	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.47, 3.57]
8.3 Ciprofloxacin vs ethambutol plus pyrazinamide	1	160	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.20, 4.69]
8.4 Ofloxacin vs rifampicin	1	31	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.79]
8.5 Moxifloxacin vs ethambutol	1	336	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.50, 3.05]
9 Total number of adverse events Show forest plot	4	712	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.96, 1.43]

9.1 Ciprofloxacin vs rifampicin	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.22, 4.56]
9.2 Ciprofloxacin vs ethambutol plus pyrazinamide	1	160	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.60, 1.24]
9.3 Ofloxacin vs ethambutol	1	156	Risk Ratio (M‐H, Fixed, 95% CI)	1.95 [0.70, 5.44]
9.4 Moxifloxacin vs ethambutol	1	336	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [1.00, 1.66]
10 Total number of adverse events, substitutions for ethambutol Show forest plot	2	492	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [1.05, 1.72]

Comparison 1. Fluoroquinolone substituted into regimen

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Comparison 2. Fluoroquinolone added to regimen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cure (sputum culture conversion) at 8 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Treatment failure at 12 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Clinical or radiological improvement at 8 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Death from any cause Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Tuberculosis‐related death Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Serious adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6.1 Levofloxacin vs no levofloxacin	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Fluoroquinolone added to regimen

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Comparison 3. Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cure (sputum culture conversion) within 2 to 3 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Treatment failure at 12 months Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Clinical or radiological improvement at 8 weeks Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Total number of adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Comparison of fluoroquinolones (levofloxacin vs ofloxacin) substituted into regimen

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Comparison 4. Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cure (sputum culture conversion within 2 to 3 weeks) Show forest plot	2	184	Risk Ratio (M‐H, Random, 95% CI)	2.10 [0.77, 5.71]

2 Treatment failure at 12 months Show forest plot	2	149	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.26, 1.47]

3 Clinical or radiological improvement at 8 weeks Show forest plot	3	333	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.92, 1.24]

4 Total number of adverse events Show forest plot	3	253	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.59, 1.64]

Comparison 4. Comparison of fluoroquinolones (sparfloxacin vs ofloxacin) added to regimens

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