Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics

ABCD Study Group; Patricia B Pavlinac; James Platts-Mills; Jie Liu; Hannah E Atlas; Jean Gratz; Darwin Operario; Elizabeth Rogawski McQuade; Dilruba Ahmed; Tahmeed Ahmed; Tahmina Alam; Per Ashorn; Henry Badji; Rajiv Bahl; Naor Bar-Zeev; Mohammod Jobayer Chisti; Jen Cornick; Aishwarya Chauhan; Ayesha De Costa; Saikat Deb; Usha Dhingra; Queen Dube; Christopher P Duggan; Bridget Freyne; Wilson Gumbi; Aneeta Hotwani; Mamun Kabir; Ohedul Islam; Furqan Kabir; Irene Kasumba; Upendo Kibwana; Karen L Kotloff; Shaila S Khan; Victor Maiden; Karim Manji; Ashka Mehta; Latif Ndeketa; Ira Praharaj; Farah Naz Qamar; Sunil Sazawal; Jonathon Simon; Benson O Singa; Sarah Somji; Samba O Sow; Milagritos D Tapia; Caroline Tigoi; Aliou Toure; Judd L Walson; Mohammad Tahir Yousafzai; Eric R Houpt

doi:10.1093/infdis/jiad252

Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics

ABCD Study Group , Patricia B Pavlinac, James Platts-Mills, Jie Liu, Hannah E Atlas, Jean Gratz, Darwin Operario, Elizabeth Rogawski McQuade, Dilruba Ahmed, Tahmeed Ahmed, Tahmina Alam, Per Ashorn, Henry Badji, Rajiv Bahl, Naor Bar-Zeev, Mohammod Jobayer Chisti, Jen Cornick, Aishwarya Chauhan, Ayesha De Costa, Saikat DebUsha Dhingra, Queen Dube, Christopher P Duggan, Bridget Freyne, Wilson Gumbi, Aneeta Hotwani, Mamun Kabir, Ohedul Islam, Furqan Kabir, Irene Kasumba, Upendo Kibwana, Karen L Kotloff, Shaila S Khan, Victor Maiden, Karim Manji, Ashka Mehta, Latif Ndeketa, Ira Praharaj, Farah Naz Qamar, Sunil Sazawal, Jonathon Simon, Benson O Singa, Sarah Somji, Samba O Sow, Milagritos D Tapia, Caroline Tigoi, Aliou Toure, Judd L Walson, Mohammad Tahir Yousafzai, Eric R Houpt

LAST, Lastentaudit

Tutkimustuotos: Artikkeli › Scientific › vertaisarvioitu

5 Sitaatiot (Scopus)

5 Lataukset (Pure)

Abstrakti

BACKGROUND: Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.

METHODS: AntiBiotics for Children with severe Diarrhea was a 7-country placebo-controlled double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens utilizing quantitative PCR and employed pathogen-specific cutoffs based on genomic target quantity in previous case control diarrhea etiology studies to identify likely and possible bacterial etiologies.

RESULTS: Among 6,692 children, the leading likely etiologies were rotavirus(21.1%), ST-ETEC(13.3%), Shigella(12.6%) and Cryptosporidium(9.6%). More than one quarter (1894[28.3%]) had a likely and 1,153(17.3%) a possible bacterial etiology. Day 3 diarrhea was less common in those randomized to azithromycin vs. placebo among children with a likely bacterial etiology (Risk Difference[RD]likely: -11.6[95%CI:-15.6, -7.6] and possible bacterial etiology (RDpossible:-8.7 [95%CI:-13.0, -4.4]) but not in other children (RDunlikely:-0.3%[95%CI:-2.9%,2.3%]). A similar association was observed for 90-day hospitalization or death (RDlikely:-3.1[95%CI:-5.3, -1.0], RDpossible: -2.3[95%CI: -4.5, -0.01], and (RDunlikely:-0.6 [95%CI:-1.9,0.6]). The magnitude of risk differences were similar among specific likely bacterial etiologies, including Shigella.

CONCLUSION: Acute watery diarrhea confirmed or presumed to be of bacterial etiology may benefit from azithromycin treatment.

Alkuperäiskieli	Englanti
Artikkeli	jiad252
Sivut	988-998
Julkaisu	JOURNAL OF INFECTIOUS DISEASES
Vuosikerta	229
Numero	4
Varhainen verkossa julkaisun päivämäärä	5 heinäk. 2023
DOI - pysyväislinkit	https://doi.org/10.1093/infdis/jiad252
Tila	Julkaistu - 15 huhtik. 2024
OKM-julkaisutyyppi	A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä

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10.1093/infdis/jiad252Lisenssi: CC BY-NC-ND

jiad252Final published version, 596 KBLisenssi: CC BY-NC-ND

https://urn.fi/URN:NBN:fi:tuni-202401151448Lisenssi: CC BY-NC-ND

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ABCD Study Group , Pavlinac, P. B., Platts-Mills, J., Liu, J., Atlas, H. E., Gratz, J., Operario, D., Rogawski McQuade, E., Ahmed, D., Ahmed, T., Alam, T., Ashorn, P., Badji, H., Bahl, R., Bar-Zeev, N., Chisti, M. J., Cornick, J., Chauhan, A., De Costa, A., ... Houpt, E. R. (2024). Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics. JOURNAL OF INFECTIOUS DISEASES, 229(4), 988-998. Artikkeli jiad252. https://doi.org/10.1093/infdis/jiad252

@article{9d4f2555912d45f3874821e3add2f2d4,

title = "Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics",

abstract = "BACKGROUND: Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.METHODS: AntiBiotics for Children with severe Diarrhea was a 7-country placebo-controlled double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens utilizing quantitative PCR and employed pathogen-specific cutoffs based on genomic target quantity in previous case control diarrhea etiology studies to identify likely and possible bacterial etiologies.RESULTS: Among 6,692 children, the leading likely etiologies were rotavirus(21.1%), ST-ETEC(13.3%), Shigella(12.6%) and Cryptosporidium(9.6%). More than one quarter (1894[28.3%]) had a likely and 1,153(17.3%) a possible bacterial etiology. Day 3 diarrhea was less common in those randomized to azithromycin vs. placebo among children with a likely bacterial etiology (Risk Difference[RD]likely: -11.6[95%CI:-15.6, -7.6] and possible bacterial etiology (RDpossible:-8.7 [95%CI:-13.0, -4.4]) but not in other children (RDunlikely:-0.3%[95%CI:-2.9%,2.3%]). A similar association was observed for 90-day hospitalization or death (RDlikely:-3.1[95%CI:-5.3, -1.0], RDpossible: -2.3[95%CI: -4.5, -0.01], and (RDunlikely:-0.6 [95%CI:-1.9,0.6]). The magnitude of risk differences were similar among specific likely bacterial etiologies, including Shigella.CONCLUSION: Acute watery diarrhea confirmed or presumed to be of bacterial etiology may benefit from azithromycin treatment.",

author = "{ABCD Study Group} and Pavlinac, {Patricia B} and James Platts-Mills and Jie Liu and Atlas, {Hannah E} and Jean Gratz and Darwin Operario and {Rogawski McQuade}, Elizabeth and Dilruba Ahmed and Tahmeed Ahmed and Tahmina Alam and Per Ashorn and Henry Badji and Rajiv Bahl and Naor Bar-Zeev and Chisti, {Mohammod Jobayer} and Jen Cornick and Aishwarya Chauhan and {De Costa}, Ayesha and Saikat Deb and Usha Dhingra and Queen Dube and Duggan, {Christopher P} and Bridget Freyne and Wilson Gumbi and Aneeta Hotwani and Mamun Kabir and Ohedul Islam and Furqan Kabir and Irene Kasumba and Upendo Kibwana and Kotloff, {Karen L} and Khan, {Shaila S} and Victor Maiden and Karim Manji and Ashka Mehta and Latif Ndeketa and Ira Praharaj and Qamar, {Farah Naz} and Sunil Sazawal and Jonathon Simon and Singa, {Benson O} and Sarah Somji and Sow, {Samba O} and Tapia, {Milagritos D} and Caroline Tigoi and Aliou Toure and Walson, {Judd L} and {Tahir Yousafzai}, Mohammad and Houpt, {Eric R}",

note = "{\textcopyright} The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.",

year = "2024",

month = apr,

day = "15",

doi = "10.1093/infdis/jiad252",

language = "English",

volume = "229",

pages = "988--998",

journal = "JOURNAL OF INFECTIOUS DISEASES",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "4",

}

ABCD Study Group , Pavlinac, PB, Platts-Mills, J, Liu, J, Atlas, HE, Gratz, J, Operario, D, Rogawski McQuade, E, Ahmed, D, Ahmed, T, Alam, T, Ashorn, P, Badji, H, Bahl, R, Bar-Zeev, N, Chisti, MJ, Cornick, J, Chauhan, A, De Costa, A, Deb, S, Dhingra, U, Dube, Q, Duggan, CP, Freyne, B, Gumbi, W, Hotwani, A, Kabir, M, Islam, O, Kabir, F, Kasumba, I, Kibwana, U, Kotloff, KL, Khan, SS, Maiden, V, Manji, K, Mehta, A, Ndeketa, L, Praharaj, I, Qamar, FN, Sazawal, S, Simon, J, Singa, BO, Somji, S, Sow, SO, Tapia, MD, Tigoi, C, Toure, A, Walson, JL, Tahir Yousafzai, M & Houpt, ER 2024, 'Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics', JOURNAL OF INFECTIOUS DISEASES, Vuosikerta 229, Nro 4, jiad252, Sivut 988-998. https://doi.org/10.1093/infdis/jiad252

Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics. / ABCD Study Group ; Pavlinac, Patricia B; Platts-Mills, James et al.
julkaisussa: JOURNAL OF INFECTIOUS DISEASES, Vuosikerta 229, Nro 4, jiad252, 15.04.2024, s. 988-998.

Tutkimustuotos: Artikkeli › Scientific › vertaisarvioitu

TY - JOUR

T1 - Azithromycin for bacterial watery diarrhea

T2 - A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics

AU - ABCD Study Group

AU - Pavlinac, Patricia B

AU - Platts-Mills, James

AU - Liu, Jie

AU - Atlas, Hannah E

AU - Gratz, Jean

AU - Operario, Darwin

AU - Rogawski McQuade, Elizabeth

AU - Ahmed, Dilruba

AU - Ahmed, Tahmeed

AU - Alam, Tahmina

AU - Ashorn, Per

AU - Badji, Henry

AU - Bahl, Rajiv

AU - Bar-Zeev, Naor

AU - Chisti, Mohammod Jobayer

AU - Cornick, Jen

AU - Chauhan, Aishwarya

AU - De Costa, Ayesha

AU - Deb, Saikat

AU - Dhingra, Usha

AU - Dube, Queen

AU - Duggan, Christopher P

AU - Freyne, Bridget

AU - Gumbi, Wilson

AU - Hotwani, Aneeta

AU - Kabir, Mamun

AU - Islam, Ohedul

AU - Kabir, Furqan

AU - Kasumba, Irene

AU - Kibwana, Upendo

AU - Kotloff, Karen L

AU - Khan, Shaila S

AU - Maiden, Victor

AU - Manji, Karim

AU - Mehta, Ashka

AU - Ndeketa, Latif

AU - Praharaj, Ira

AU - Qamar, Farah Naz

AU - Sazawal, Sunil

AU - Simon, Jonathon

AU - Singa, Benson O

AU - Somji, Sarah

AU - Sow, Samba O

AU - Tapia, Milagritos D

AU - Tigoi, Caroline

AU - Toure, Aliou

AU - Walson, Judd L

AU - Tahir Yousafzai, Mohammad

AU - Houpt, Eric R

PY - 2024/4/15

Y1 - 2024/4/15

N2 - BACKGROUND: Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.METHODS: AntiBiotics for Children with severe Diarrhea was a 7-country placebo-controlled double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens utilizing quantitative PCR and employed pathogen-specific cutoffs based on genomic target quantity in previous case control diarrhea etiology studies to identify likely and possible bacterial etiologies.RESULTS: Among 6,692 children, the leading likely etiologies were rotavirus(21.1%), ST-ETEC(13.3%), Shigella(12.6%) and Cryptosporidium(9.6%). More than one quarter (1894[28.3%]) had a likely and 1,153(17.3%) a possible bacterial etiology. Day 3 diarrhea was less common in those randomized to azithromycin vs. placebo among children with a likely bacterial etiology (Risk Difference[RD]likely: -11.6[95%CI:-15.6, -7.6] and possible bacterial etiology (RDpossible:-8.7 [95%CI:-13.0, -4.4]) but not in other children (RDunlikely:-0.3%[95%CI:-2.9%,2.3%]). A similar association was observed for 90-day hospitalization or death (RDlikely:-3.1[95%CI:-5.3, -1.0], RDpossible: -2.3[95%CI: -4.5, -0.01], and (RDunlikely:-0.6 [95%CI:-1.9,0.6]). The magnitude of risk differences were similar among specific likely bacterial etiologies, including Shigella.CONCLUSION: Acute watery diarrhea confirmed or presumed to be of bacterial etiology may benefit from azithromycin treatment.

AB - BACKGROUND: Bacterial pathogens cause substantial diarrhea morbidity and mortality among children living in endemic settings, yet antimicrobial treatment is only recommended for dysentery or suspected cholera.METHODS: AntiBiotics for Children with severe Diarrhea was a 7-country placebo-controlled double-blind efficacy trial of azithromycin in children 2-23 months of age with watery diarrhea accompanied by dehydration or malnutrition. We tested fecal samples for enteric pathogens utilizing quantitative PCR and employed pathogen-specific cutoffs based on genomic target quantity in previous case control diarrhea etiology studies to identify likely and possible bacterial etiologies.RESULTS: Among 6,692 children, the leading likely etiologies were rotavirus(21.1%), ST-ETEC(13.3%), Shigella(12.6%) and Cryptosporidium(9.6%). More than one quarter (1894[28.3%]) had a likely and 1,153(17.3%) a possible bacterial etiology. Day 3 diarrhea was less common in those randomized to azithromycin vs. placebo among children with a likely bacterial etiology (Risk Difference[RD]likely: -11.6[95%CI:-15.6, -7.6] and possible bacterial etiology (RDpossible:-8.7 [95%CI:-13.0, -4.4]) but not in other children (RDunlikely:-0.3%[95%CI:-2.9%,2.3%]). A similar association was observed for 90-day hospitalization or death (RDlikely:-3.1[95%CI:-5.3, -1.0], RDpossible: -2.3[95%CI: -4.5, -0.01], and (RDunlikely:-0.6 [95%CI:-1.9,0.6]). The magnitude of risk differences were similar among specific likely bacterial etiologies, including Shigella.CONCLUSION: Acute watery diarrhea confirmed or presumed to be of bacterial etiology may benefit from azithromycin treatment.

U2 - 10.1093/infdis/jiad252

DO - 10.1093/infdis/jiad252

M3 - Article

C2 - 37405406

SN - 0022-1899

VL - 229

SP - 988

EP - 998

JO - JOURNAL OF INFECTIOUS DISEASES

JF - JOURNAL OF INFECTIOUS DISEASES

IS - 4

M1 - jiad252

ER -

Azithromycin for bacterial watery diarrhea: A reanalysis of the AntiBiotics for Children with severe Diarrhea (ABCD) trial incorporating molecular diagnostics

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