Randomized, Controlled Trial of Oral Ribavirin for Japanese Encephalitis in Children in Uttar Pradesh, India
Identifieur interne : 002C17 ( Main/Exploration ); précédent : 002C16; suivant : 002C18Randomized, Controlled Trial of Oral Ribavirin for Japanese Encephalitis in Children in Uttar Pradesh, India
Auteurs : Rashmi Kumar [Inde] ; Piyush Tripathi [Inde] ; Madan Baranwal [Inde] ; Sudhakar Singh [Inde] ; Sanjeev Tripathi [Inde] ; Gopa Banerjee [Inde]Source :
- Clinical Infectious Diseases [ 1058-4838 ] ; 2009.
Abstract
Background. Japanese encephalitis is associated with high rates of mortality and disabling sequelae. To date, no specific antiviral has proven to be of benefit for this condition. We attempted to determine the efficacy of oral ribavirin treatment for reducing early mortality among children with Japanese encephalitis in Uttar Pradesh, India. Methods. Children (age, 6 months to 15 years) who had been hospitalized with acute febrile encephalopathy (a ⩽2-week history of fever plus altered sensorium) were tested for the presence of immunoglobulin M antibodies to Japanese encephalitis virus with commercial immunoglobulin M capture enzyme-linked immunosorbent assay. Children with positive results were randomized to receive either ribavirin (10 mg/kg per day in 4 divided doses for 7 days) or placebo syrup through nasogastric tube or by mouth. The primary outcome was early mortality; secondary outcome measures were early (at hospital discharge; normal or nearly normal, independent functioning, dependent, vegetative state, or death) outcome, time to resolution of fever, time to resumption of oral feeding, duration of hospitalization, and late outcome (⩾3 months after hospital discharge). The study was double-blind, and analysis was by intention to treat. Results. A total of 153 patients were enrolled during a 3-year period; 70 patients received ribavirin, and 83 received placebo. There was no statistically significant difference between the 2 groups in the early mortality rate: 19 (27.1%) of 70 ribavirin recipients and 21 (25.3%) of 83 placebo recipients died (odds ratio, 1.10; 95% confidence interval, 0.5–2.4). No statistically significant differences in secondary outcome measures were found. Conclusions. For the dosage schedule used in our study, oral ribavirin has no effect in reducing early mortality associated with Japanese encephalitis. Trial registration. ClinicalTrials.gov identifier: .
Url:
DOI: 10.1086/596309
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 001998
- to stream Istex, to step Curation: 001998
- to stream Istex, to step Checkpoint: 000B80
- to stream Main, to step Merge: 002C71
- to stream Main, to step Curation: 002C17
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>Randomized, Controlled Trial of Oral Ribavirin for Japanese Encephalitis in Children in Uttar Pradesh, India</title><author><name sortKey="Kumar, Rashmi" sort="Kumar, Rashmi" uniqKey="Kumar R" first="Rashmi" last="Kumar">Rashmi Kumar</name></author><author><name sortKey="Tripathi, Piyush" sort="Tripathi, Piyush" uniqKey="Tripathi P" first="Piyush" last="Tripathi">Piyush Tripathi</name></author><author><name sortKey="Baranwal, Madan" sort="Baranwal, Madan" uniqKey="Baranwal M" first="Madan" last="Baranwal">Madan Baranwal</name></author><author><name sortKey="Singh, Sudhakar" sort="Singh, Sudhakar" uniqKey="Singh S" first="Sudhakar" last="Singh">Sudhakar Singh</name></author><author><name sortKey="Tripathi, Sanjeev" sort="Tripathi, Sanjeev" uniqKey="Tripathi S" first="Sanjeev" last="Tripathi">Sanjeev Tripathi</name></author><author><name sortKey="Banerjee, Gopa" sort="Banerjee, Gopa" uniqKey="Banerjee G" first="Gopa" last="Banerjee">Gopa Banerjee</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:BD5DFABB12C63D54A39FA24AAC8D14AC40A14B95</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1086/596309</idno><idno type="url">https://api.istex.fr/ark:/67375/HXZ-1J1T0NFF-R/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001998</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001998</idno><idno type="wicri:Area/Istex/Curation">001998</idno><idno type="wicri:Area/Istex/Checkpoint">000B80</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000B80</idno><idno type="wicri:doubleKey">1058-4838:2009:Kumar R:randomized:controlled:trial</idno><idno type="wicri:Area/Main/Merge">002C71</idno><idno type="wicri:Area/Main/Curation">002C17</idno><idno type="wicri:Area/Main/Exploration">002C17</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">Randomized, Controlled Trial of Oral Ribavirin for Japanese Encephalitis in Children in Uttar Pradesh, India</title><author><name sortKey="Kumar, Rashmi" sort="Kumar, Rashmi" uniqKey="Kumar R" first="Rashmi" last="Kumar">Rashmi Kumar</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Departments of Pediatrics, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author><author><name sortKey="Tripathi, Piyush" sort="Tripathi, Piyush" uniqKey="Tripathi P" first="Piyush" last="Tripathi">Piyush Tripathi</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Departments of Pediatrics, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author><author><name sortKey="Baranwal, Madan" sort="Baranwal, Madan" uniqKey="Baranwal M" first="Madan" last="Baranwal">Madan Baranwal</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Departments of Pediatrics, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author><author><name sortKey="Singh, Sudhakar" sort="Singh, Sudhakar" uniqKey="Singh S" first="Sudhakar" last="Singh">Sudhakar Singh</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Departments of Pediatrics, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author><author><name sortKey="Tripathi, Sanjeev" sort="Tripathi, Sanjeev" uniqKey="Tripathi S" first="Sanjeev" last="Tripathi">Sanjeev Tripathi</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Departments of Pediatrics, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author><author><name sortKey="Banerjee, Gopa" sort="Banerjee, Gopa" uniqKey="Banerjee G" first="Gopa" last="Banerjee">Gopa Banerjee</name><affiliation wicri:level="1"><country xml:lang="fr">Inde</country><wicri:regionArea>Microbiology, Chhatrapati Shahuji Maharaj Medical University, Lucknow, Uttar Pradesh</wicri:regionArea><wicri:noRegion>Uttar Pradesh</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Clinical Infectious Diseases</title><title level="j" type="abbrev">Clinical Infectious Diseases</title><idno type="ISSN">1058-4838</idno><idno type="eISSN">1537-6591</idno><imprint><publisher>The University of Chicago Press</publisher><date type="published">2009</date><biblScope unit="vol">48</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="400">400</biblScope><biblScope unit="page" to="406">406</biblScope></imprint><idno type="ISSN">1058-4838</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1058-4838</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background. Japanese encephalitis is associated with high rates of mortality and disabling sequelae. To date, no specific antiviral has proven to be of benefit for this condition. We attempted to determine the efficacy of oral ribavirin treatment for reducing early mortality among children with Japanese encephalitis in Uttar Pradesh, India. Methods. Children (age, 6 months to 15 years) who had been hospitalized with acute febrile encephalopathy (a ⩽2-week history of fever plus altered sensorium) were tested for the presence of immunoglobulin M antibodies to Japanese encephalitis virus with commercial immunoglobulin M capture enzyme-linked immunosorbent assay. Children with positive results were randomized to receive either ribavirin (10 mg/kg per day in 4 divided doses for 7 days) or placebo syrup through nasogastric tube or by mouth. The primary outcome was early mortality; secondary outcome measures were early (at hospital discharge; normal or nearly normal, independent functioning, dependent, vegetative state, or death) outcome, time to resolution of fever, time to resumption of oral feeding, duration of hospitalization, and late outcome (⩾3 months after hospital discharge). The study was double-blind, and analysis was by intention to treat. Results. A total of 153 patients were enrolled during a 3-year period; 70 patients received ribavirin, and 83 received placebo. There was no statistically significant difference between the 2 groups in the early mortality rate: 19 (27.1%) of 70 ribavirin recipients and 21 (25.3%) of 83 placebo recipients died (odds ratio, 1.10; 95% confidence interval, 0.5–2.4). No statistically significant differences in secondary outcome measures were found. Conclusions. For the dosage schedule used in our study, oral ribavirin has no effect in reducing early mortality associated with Japanese encephalitis. Trial registration. ClinicalTrials.gov identifier: .</div></front></TEI><affiliations><list><country><li>Inde</li></country></list><tree><country name="Inde"><noRegion><name sortKey="Kumar, Rashmi" sort="Kumar, Rashmi" uniqKey="Kumar R" first="Rashmi" last="Kumar">Rashmi Kumar</name></noRegion><name sortKey="Banerjee, Gopa" sort="Banerjee, Gopa" uniqKey="Banerjee G" first="Gopa" last="Banerjee">Gopa Banerjee</name><name sortKey="Baranwal, Madan" sort="Baranwal, Madan" uniqKey="Baranwal M" first="Madan" last="Baranwal">Madan Baranwal</name><name sortKey="Singh, Sudhakar" sort="Singh, Sudhakar" uniqKey="Singh S" first="Sudhakar" last="Singh">Sudhakar Singh</name><name sortKey="Tripathi, Piyush" sort="Tripathi, Piyush" uniqKey="Tripathi P" first="Piyush" last="Tripathi">Piyush Tripathi</name><name sortKey="Tripathi, Sanjeev" sort="Tripathi, Sanjeev" uniqKey="Tripathi S" first="Sanjeev" last="Tripathi">Sanjeev Tripathi</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/SrasV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002C17 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002C17 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= SrasV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:BD5DFABB12C63D54A39FA24AAC8D14AC40A14B95
|texte= Randomized, Controlled Trial of Oral Ribavirin for Japanese Encephalitis in Children in Uttar Pradesh, India
}}
| This area was generated with Dilib version V0.6.33. |  |