Description of studies: data available, exclusion criteria, treatment characteristics and enrolment

Years of enrolment2005–20112008–20112008–20102013–20152014–2016
StatusPublished [6, 7]Published [11]Published [12]Ongoing (see text for details)Ongoing (see text for details)
Level of data availableIndividual patientAggregateAggregateIndividual patientIndividual patient
Duration of post-treatment follow-up years21211
Exclusion criteria
 Prior treatment with  second-line drugsExcludedExcludedExcludedExcluded
 Baseline XDR-TBExcludedExcludedExcludedExcluded
 Baseline  fluoroquinolone  resistanceExcludedExcluded if moxifloxacin#
 Baseline second-line  injectable resistanceExcluded if dualExcluded if dual
Baseline DST performed
 RifampinYes (culture)Yes (culture)Yes (culture)Yes (culture, molecular)Yes (culture, molecular)
 IsoniazidYes (culture)Yes (culture)Yes (culture)Yes (culture, molecular)Yes (culture, molecular)
 KanamycinYes (culture)Yes (culture)Yes (culture)Yes (culture, molecular)Yes (culture)
 OfloxacinYes (culture)Yes (culture)Yes (culture)Yes (culture, molecular)Yes (culture)
 Prothionamide or  ethionamideYes (culture)NoYes (culture)NoYes (culture)
 ClofazimineYes (culture)NoNoNoNo
 PyrazinamideYes (culture)NoNoYes (culture)Yes (culture)
 EthambutolYes (culture)NoYes (culture)Yes (culture)Yes (culture)
Treatment characteristics
 Directly observed  treatmentDaily throughoutDaily throughoutDaily throughoutDaily throughoutDaily throughout
 Hospitalisation  compulsory versus  selective, durationCompulsory, intensive phaseCompulsory, intensive phaseSelective, intensive phaseSelective, variableSelective, variable
 Psychosocial,  economic or  nutritional support  provided to patientsYesYesYesYesYes
 Intensive phase+  duration months  (maximum)4 (6)4 (6)4 (6)4 (6)4 (8)
 Continuation phase  duration months58855
 Second-line  injectable typeKanamycinKanamycinKanamycinCapreomycin or kanamycin§Kanamycin or amikacin§
 Fluoroquinolone  (used in both  intensive and  continuation phases  in all studies)  type-doseGatifloxacin-high (weight-based high dose; maximum 800 mg daily)Gatifloxacin-usual (400 mg daily)Gatifloxacin-high (weight-based high dose; maximum 800 mg daily)Moxifloxacin-usual (400 mg daily)Moxifloxacin-usual (400 mg daily)
 Isoniazid (used  only in intensive  phase in all  studies) doseHighUsualHighHighHigh
 Prothionamide  used in what  phaseIntensiveIntensiveIntensiveThroughoutThroughout
 Clofazimine,  pyrazinamide,  ethambutolUsed in all studies, in intensive and continuation phases

XDR: extensively drug-resistant; TB: tuberculosis; DST: drug susceptibility test. #: participants with ofloxacin-resistant strains that were susceptible to moxifloxacin could be included; : resistance to kanamycin plus one other second-line injectable; +: defined as the period where a second-line injectable agent is utilised; §: in Uzbekistan, participants initiated treatment with capreomycin and were switched to kanamycin if DSTs demonstrated kanamycin susceptibility; in Swaziland, amikacin was used in participants with kanamycin-resistant strains.