@article{fdi:010081084, title = {{I}mpact of systematic early tuberculosis detection using {X}pert {MTB}/{RIF} {U}ltra in children with severe pneumonia in high tuberculosis burden countries ({TB}-{S}peed pneumonia) : a stepped wedge cluster randomized trial}, author = {{V}essi{\`e}re, {A}. and {F}ont, {H}. and {G}abillard, {D}. and {A}donis-{K}offi, {L}. and {B}orand, {L}. and {C}habala, {C}. and {K}hosa, {C}. and {M}avale, {S}. and {M}oh, {R}. and {M}ulenga, {V}. and {M}wanga-{A}mumpere, {J}. and {T}aguebue, {J}. {V}. and {E}ang, {M}. {T}. and {D}elacourt, {C}. and {S}eddon, {J}. {A}. and {L}ounnas, {M}anon and {G}odreuil, {S}. and {W}obudeya, {E}. and {B}onnet, {M}aryline and {M}arcy, {O}.}, editor = {}, language = {{ENG}}, abstract = {{B}ackground: {I}n high tuberculosis ({TB}) burden settings, there is growing evidence that {TB} is common in children with pneumonia, the leading cause of death in children under 5 years worldwide. {T}he current {WHO} standard of care ({SOC}) for young children with pneumonia considers a diagnosis of {TB} only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. {A}s a result, many children with {TB}-associated severe pneumonia are currently missed or diagnosed too late. {W}e therefore propose a diagnostic trial to assess the impact on mortality of adding the systematic early detection of {TB} using {X}pert {MTB}/{RIF} {U}ltra ({U}ltra) performed on nasopharyngeal aspirates ({NPA}) and stool samples to the {WHO} {SOC} for children with severe pneumonia, followed by immediate initiation of anti-{TB} treatment in children testing positive on any of the samples. {M}ethods: {TB}-{S}peed {P}neumonia is a pragmatic stepped-wedge cluster randomized controlled trial conducted in six countries with high {TB} incidence rate ({C}ote d'{I}voire, {C}ameroon, {U}ganda, {M}ozambique, {Z}ambia and {C}ambodia). {W}e will enrol 3780 children under 5 years presenting with {WHO}-defined severe pneumonia across 15 hospitals over 18 months. {A}ll hospitals will start managing children using the {WHO} {SOC} for severe pneumonia; one hospital will be randomly selected to switch to the intervention every 5 weeks. {T}he intervention consists of the {WHO} {SOC} plus rapid {TB} detection on the day of admission using {U}ltra performed on 1 nasopharyngeal aspirate and 1 stool sample. {A}ll children will be followed for 3 months, with systematic trial visits at day 3, discharge, 2 weeks post-discharge, and week 12. {T}he primary endpoint is all-cause mortality 12 weeks after inclusion. {Q}ualitative and health economic evaluations are embedded in the trial. {D}iscussion: {I}n addition to testing the main hypothesis that molecular detection and early treatment will reduce {TB} mortality in children, the strength of such pragmatic research is that it provides some evidence regarding the feasibility of the intervention as part of routine care. {S}hould this intervention be successful, safe and well tolerated, it could be systematically implemented at district hospital level where children with severe pneumonia are referred.}, keywords = {{C}hildren ; {P}neumonia ; {T}uberculosis ; {N}asopharyngeal aspirate ; {S}tool ; {X}pert ; {MTB} ; {RIF} ultra ; {AFRIQUE} {SUBSAHARIENNE} ; {ASIE} {DU} {SUD} {EST} ; {CAMEROUN} ; {COTE} {D}’{IVOIRE} ; {MOZAMBIQUE} ; {OUGANDA} ; {ZAMBIE} ; {CAMBODGE}}, booktitle = {}, journal = {{BMC} {P}ediatrics}, volume = {21}, numero = {1}, pages = {136 [12 p.]}, year = {2021}, DOI = {10.1186/s12887-021-02576-5}, URL = {https://www.documentation.ird.fr/hor/fdi:010081084}, }