Pathogen Detection in HIV-infected Children With Non-malarial Febrile Illnesses Using Metagenomic Sequencing
NCT ID: NCT05085158
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
138 participants
OBSERVATIONAL
2023-01-01
2024-10-01
Brief Summary
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Detailed Description
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Considering these limitations, there is a pressing need for sensitive pathogen-detection-based approaches such as shotgun metagenomics sequencing (sMGS). Ultimately, in the near future, integration of whole-genome based approaches such as long-read sequencing technologies to tropical fevers is urgently needed to improve management of severe and treatable infections especially among the vulnerable groups such as HIV-infected children and adolescents presenting with NMFIs.
This project aims to utilise sMGS to characterize microbial pathogens in HIV-infected Ugandan children and adolescents admitted to Baylor College of Medicine Children's Foundation - Uganda with NMFIs and associated clinical presentations or comorbidities.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group 1
HIV-infected children with non-malarial febrile illnesses (NMFIs) less than 5 years old
No interventions assigned to this group
Group 2
HIV-infected children and adolescents with non-malarial febrile illnesses (NMFIs) but less than 15 years old
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
14 Years
ALL
No
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
Makerere University
OTHER
Responsible Party
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Principal Investigators
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Gerald Mboowa, PhD
Role: PRINCIPAL_INVESTIGATOR
Infectious Diseases Institute, Makerere University
Locations
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Baylor College of Medicine Children's Foundation-Uganda
Mulago, , Uganda
Countries
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References
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Pokharel S, White LJ, Aguas R, Celhay O, Pelle KG, Dittrich S. Algorithm in the Diagnosis of Febrile Illness Using Pathogen-specific Rapid Diagnostic Tests. Clin Infect Dis. 2020 May 23;70(11):2262-2269. doi: 10.1093/cid/ciz665.
Ramesh A, Nakielny S, Hsu J, Kyohere M, Byaruhanga O, de Bourcy C, Egger R, Dimitrov B, Juan YF, Sheu J, Wang J, Kalantar K, Langelier C, Ruel T, Mpimbaza A, Wilson MR, Rosenthal PJ, DeRisi JL. Metagenomic next-generation sequencing of samples from pediatric febrile illness in Tororo, Uganda. PLoS One. 2019 Jun 20;14(6):e0218318. doi: 10.1371/journal.pone.0218318. eCollection 2019.
Maze MJ, Bassat Q, Feasey NA, Mandomando I, Musicha P, Crump JA. The epidemiology of febrile illness in sub-Saharan Africa: implications for diagnosis and management. Clin Microbiol Infect. 2018 Aug;24(8):808-814. doi: 10.1016/j.cmi.2018.02.011. Epub 2018 Feb 15.
Decuypere S, Maltha J, Deborggraeve S, Rattray NJ, Issa G, Berenger K, Lompo P, Tahita MC, Ruspasinghe T, McConville M, Goodacre R, Tinto H, Jacobs J, Carapetis JR. Towards Improving Point-of-Care Diagnosis of Non-malaria Febrile Illness: A Metabolomics Approach. PLoS Negl Trop Dis. 2016 Mar 4;10(3):e0004480. doi: 10.1371/journal.pntd.0004480. eCollection 2016 Mar.
Pondei, Kemebradikumo, Onyaye E. Kunle-Olowu, and Oliemen Peterside.
https://www.unaids.org/en/resources/presscentre/featurestories/2019/december/uganda-treating-hiv-positive-children-speed-and-skill
Miller S, Naccache SN, Samayoa E, Messacar K, Arevalo S, Federman S, Stryke D, Pham E, Fung B, Bolosky WJ, Ingebrigtsen D, Lorizio W, Paff SM, Leake JA, Pesano R, DeBiasi R, Dominguez S, Chiu CY. Laboratory validation of a clinical metagenomic sequencing assay for pathogen detection in cerebrospinal fluid. Genome Res. 2019 May;29(5):831-842. doi: 10.1101/gr.238170.118. Epub 2019 Apr 16.
Schlaberg R, Chiu CY, Miller S, Procop GW, Weinstock G; Professional Practice Committee and Committee on Laboratory Practices of the American Society for Microbiology; Microbiology Resource Committee of the College of American Pathologists. Validation of Metagenomic Next-Generation Sequencing Tests for Universal Pathogen Detection. Arch Pathol Lab Med. 2017 Jun;141(6):776-786. doi: 10.5858/arpa.2016-0539-RA. Epub 2017 Feb 7.
Moreira-Silva SF, Zandonade E, Frauches DO, Machado EA, Lopes LI, Duque LL, Querido PP, Miranda AE. Comorbidities in children and adolescents with AIDS acquired by HIV vertical transmission in Vitoria, Brazil. PLoS One. 2013 Dec 4;8(12):e82027. doi: 10.1371/journal.pone.0082027. eCollection 2013.
Gu W, Miller S, Chiu CY. Clinical Metagenomic Next-Generation Sequencing for Pathogen Detection. Annu Rev Pathol. 2019 Jan 24;14:319-338. doi: 10.1146/annurev-pathmechdis-012418-012751. Epub 2018 Oct 24.
Naccache SN, Federman S, Veeraraghavan N, Zaharia M, Lee D, Samayoa E, Bouquet J, Greninger AL, Luk KC, Enge B, Wadford DA, Messenger SL, Genrich GL, Pellegrino K, Grard G, Leroy E, Schneider BS, Fair JN, Martinez MA, Isa P, Crump JA, DeRisi JL, Sittler T, Hackett J Jr, Miller S, Chiu CY. A cloud-compatible bioinformatics pipeline for ultrarapid pathogen identification from next-generation sequencing of clinical samples. Genome Res. 2014 Jul;24(7):1180-92. doi: 10.1101/gr.171934.113. Epub 2014 Jun 4.
Kalantar KL, Carvalho T, de Bourcy CFA, Dimitrov B, Dingle G, Egger R, Han J, Holmes OB, Juan YF, King R, Kislyuk A, Lin MF, Mariano M, Morse T, Reynoso LV, Cruz DR, Sheu J, Tang J, Wang J, Zhang MA, Zhong E, Ahyong V, Lay S, Chea S, Bohl JA, Manning JE, Tato CM, DeRisi JL. IDseq-An open source cloud-based pipeline and analysis service for metagenomic pathogen detection and monitoring. Gigascience. 2020 Oct 15;9(10):giaa111. doi: 10.1093/gigascience/giaa111.
Gyarmati P, Kjellander C, Aust C, Song Y, Ohrmalm L, Giske CG. Metagenomic analysis of bloodstream infections in patients with acute leukemia and therapy-induced neutropenia. Sci Rep. 2016 Mar 21;6:23532. doi: 10.1038/srep23532.
Kwak J, Park J. What we can see from very small size sample of metagenomic sequences. BMC Bioinformatics. 2018 Nov 3;19(1):399. doi: 10.1186/s12859-018-2431-8.
Other Identifiers
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EDCTP - TMA2020CDF-3159
Identifier Type: -
Identifier Source: org_study_id
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