Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial.
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| Title: | Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial. |
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| Authors: | Domínguez-Rodríguez S; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain. sara.dominguez.r@gmail.com.; Universidad Europea, Madrid, Spain. sara.dominguez.r@gmail.com., Lora D; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Spanish Clinical Research Network (SCReN), Madrid, Spain.; Facultad de Estudios Estadísticos, Universidad Complutense de Madrid (UCM), Madrid, Spain., Tagarro A; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Universidad Europea, Madrid, Spain.; Servicio de Pediatría, Hospital Universitario Infanta Sofía, Servicio Madrileño de Salud (SERMAS), Madrid, Spain., Moraleda C; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Servicio de Pediatría, Hospital Universitario, Servicio Madrileño de Salud (SERMAS), 12 de Octubre, Madrid, Spain., Ballesteros Á; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain., Madrid L; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Department of Infectious Disease Epidemiology, London, School of Hygiene & Tropical Medicine , London, UK., Manukyan L; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain., Marcy O; Université de Bordeaux, Bordeaux Population Health, GHiGS, Inserm U1219, IRD EMR271, Bordeaux, France., Leroy V; Institut National de La Santé Et de La Recherche Médicale (Inserm), CERPOP, University Toulouse 3, Toulouse, France., Nardone A; Penta-Onlus Foundation (PENTA), Padua, Italy., Burger D; Stichting Katholieke Universiteit-Radboudumc (RUMC), Nijmegen, The Netherlands., Bassat Q; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.; Pediatrics Department, Hospital Sant Joan de Déu, I, Universitat de Barcelona, Barcelona, Spain.; ICREA, Pg. Lluís Companys 23, Barcelona, 08010, Spain.; Centro de Investigação Em Saúde de Manhiça (CISM), Maputo, Mozambique.; Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain., Bates M; University of Lincoln, Lincoln, UK., Moh R; Unité Pédagogique de Dermatologie Et Infectiologie, UFR Sciences Médicales, Programme PAC-CI, Ivory Coast, Abidjan, Côte d'Ivoire., Tam PI; Kamuzu University Health Sciences, Blantyre, Malawi.; Liverpool School of Tropical Medicine (LSTM), Malawi-Liverpool Wellcome Programme (MLW), Blantyre, Malawi., Mvalo T; Lilongwe Medical Relief Trust (LMRFT), UNC Project Malawi, Lilongwe, Malawi., Magallhaes J; Centro de Investigação Em Saúde de Manhiça (CISM), Maputo, Mozambique., Buck WC; David Geffen School of Medicine, University of California Los Angeles, Los Angeles, USA.; Universidade Eduardo Mondlane (UEM), Maputo, Mozambique., Sacarlal J; Universidade Eduardo Mondlane (UEM), Maputo, Mozambique., Mussime V; Department of Paediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.; Joint Clinical Research Centre, Kampala, Uganda., Chabala C; School of Medicine, University of Zambia, Lusaka, Zambia., Mujuru HA; University of Zimbabwe, Harare, Zimbabwe., Rojo P; Spanish Clinical Research Network (SCReN), Madrid, Spain.; Servicio de Pediatría, Hospital Universitario, Servicio Madrileño de Salud (SERMAS), 12 de Octubre, Madrid, Spain.; Facultad de Medicina, Universidad Complutense, Madrid, Spain. |
| Corporate Authors: | EMPIRICAL group |
| Source: | Trials [Trials] 2025 Apr 30; Vol. 26 (1), pp. 144. Date of Electronic Publication: 2025 Apr 30. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40307889 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Domínguez-Rodríguez+S%22">Domínguez-Rodríguez S</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain. sara.dominguez.r@gmail.com.; Universidad Europea, Madrid, Spain. sara.dominguez.r@gmail.com.<br /><searchLink fieldCode="AU" term="%22Lora+D%22">Lora D</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Spanish Clinical Research Network (SCReN), Madrid, Spain.; Facultad de Estudios Estadísticos, Universidad Complutense de Madrid (UCM), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Tagarro+A%22">Tagarro A</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Universidad Europea, Madrid, Spain.; Servicio de Pediatría, Hospital Universitario Infanta Sofía, Servicio Madrileño de Salud (SERMAS), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Moraleda+C%22">Moraleda C</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Servicio de Pediatría, Hospital Universitario, Servicio Madrileño de Salud (SERMAS), 12 de Octubre, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Ballesteros+Á%22">Ballesteros Á</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Madrid+L%22">Madrid L</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.; Department of Infectious Disease Epidemiology, London, School of Hygiene & Tropical Medicine , London, UK.<br /><searchLink fieldCode="AU" term="%22Manukyan+L%22">Manukyan L</searchLink>; Instituto de Investigación Sanitaria Hospital (imas12), Fundación Biomedica del Hospital Universitario (FIB-H12O), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Marcy+O%22">Marcy O</searchLink>; Université de Bordeaux, Bordeaux Population Health, GHiGS, Inserm U1219, IRD EMR271, Bordeaux, France.<br /><searchLink fieldCode="AU" term="%22Leroy+V%22">Leroy V</searchLink>; Institut National de La Santé Et de La Recherche Médicale (Inserm), CERPOP, University Toulouse 3, Toulouse, France.<br /><searchLink fieldCode="AU" term="%22Nardone+A%22">Nardone A</searchLink>; Penta-Onlus Foundation (PENTA), Padua, Italy.<br /><searchLink fieldCode="AU" term="%22Burger+D%22">Burger D</searchLink>; Stichting Katholieke Universiteit-Radboudumc (RUMC), Nijmegen, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Bassat+Q%22">Bassat Q</searchLink>; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.; Pediatrics Department, Hospital Sant Joan de Déu, I, Universitat de Barcelona, Barcelona, Spain.; ICREA, Pg. Lluís Companys 23, Barcelona, 08010, Spain.; Centro de Investigação Em Saúde de Manhiça (CISM), Maputo, Mozambique.; Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Bates+M%22">Bates M</searchLink>; University of Lincoln, Lincoln, UK.<br /><searchLink fieldCode="AU" term="%22Moh+R%22">Moh R</searchLink>; Unité Pédagogique de Dermatologie Et Infectiologie, UFR Sciences Médicales, Programme PAC-CI, Ivory Coast, Abidjan, Côte d'Ivoire.<br /><searchLink fieldCode="AU" term="%22Tam+PI%22">Tam PI</searchLink>; Kamuzu University Health Sciences, Blantyre, Malawi.; Liverpool School of Tropical Medicine (LSTM), Malawi-Liverpool Wellcome Programme (MLW), Blantyre, Malawi.<br /><searchLink fieldCode="AU" term="%22Mvalo+T%22">Mvalo T</searchLink>; Lilongwe Medical Relief Trust (LMRFT), UNC Project Malawi, Lilongwe, Malawi.<br /><searchLink fieldCode="AU" term="%22Magallhaes+J%22">Magallhaes J</searchLink>; Centro de Investigação Em Saúde de Manhiça (CISM), Maputo, Mozambique.<br /><searchLink fieldCode="AU" term="%22Buck+WC%22">Buck WC</searchLink>; David Geffen School of Medicine, University of California Los Angeles, Los Angeles, USA.; Universidade Eduardo Mondlane (UEM), Maputo, Mozambique.<br /><searchLink fieldCode="AU" term="%22Sacarlal+J%22">Sacarlal J</searchLink>; Universidade Eduardo Mondlane (UEM), Maputo, Mozambique.<br /><searchLink fieldCode="AU" term="%22Mussime+V%22">Mussime V</searchLink>; Department of Paediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.; Joint Clinical Research Centre, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Chabala+C%22">Chabala C</searchLink>; School of Medicine, University of Zambia, Lusaka, Zambia.<br /><searchLink fieldCode="AU" term="%22Mujuru+HA%22">Mujuru HA</searchLink>; University of Zimbabwe, Harare, Zimbabwe.<br /><searchLink fieldCode="AU" term="%22Rojo+P%22">Rojo P</searchLink>; Spanish Clinical Research Network (SCReN), Madrid, Spain.; Servicio de Pediatría, Hospital Universitario, Servicio Madrileño de Salud (SERMAS), 12 de Octubre, Madrid, Spain.; Facultad de Medicina, Universidad Complutense, Madrid, Spain. – Name: AuthorCorporate Label: Corporate Authors Group: Au Data: <searchLink fieldCode="CA" term="%22EMPIRICAL+group%22">EMPIRICAL group</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101263253%22">Trials</searchLink> [Trials] 2025 Apr 30; Vol. 26 (1), pp. 144. <i>Date of Electronic Publication: </i>2025 Apr 30. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Clinical Trial Protocol – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101263253 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1745-6215 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217456215%22">17456215 </searchLink><i>NLM ISO Abbreviation: </i>Trials <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40307889 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1186/s13063-025-08841-7 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 144 Titles: – TitleFull: Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Domínguez-Rodríguez S – PersonEntity: Name: NameFull: Lora D – PersonEntity: Name: NameFull: Tagarro A – PersonEntity: Name: NameFull: Moraleda C – PersonEntity: Name: NameFull: Ballesteros Á – PersonEntity: Name: NameFull: Madrid L – PersonEntity: Name: NameFull: Manukyan L – PersonEntity: Name: NameFull: Marcy O – PersonEntity: Name: NameFull: Leroy V – PersonEntity: Name: NameFull: Nardone A – PersonEntity: Name: NameFull: Burger D – PersonEntity: Name: NameFull: Bassat Q – PersonEntity: Name: NameFull: Bates M – PersonEntity: Name: NameFull: Moh R – PersonEntity: Name: NameFull: Tam PI – PersonEntity: Name: NameFull: Mvalo T – PersonEntity: Name: NameFull: Magallhaes J – PersonEntity: Name: NameFull: Buck WC – PersonEntity: Name: NameFull: Sacarlal J – PersonEntity: Name: NameFull: Mussime V – PersonEntity: Name: NameFull: Chabala C – PersonEntity: Name: NameFull: Mujuru HA – PersonEntity: Name: NameFull: Rojo P IsPartOfRelationships: – BibEntity: Dates: – D: 30 M: 04 Text: 2025 Apr 30 Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 1745-6215 Numbering: – Type: volume Value: 26 – Type: issue Value: 1 Titles: – TitleFull: Trials Type: main |
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