Clinical and Laboratory Factors for the Progression of Severe Dengue Among Hospitalized Patients During an Upsurge

NCT06697041 | Completed

• 1 other identifier: PR-23077
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis (if any): Not applicable Objectives: To identify factors for progression to severe Dengue in hospitalized patients. Methods: Prospective Observational study

Conditions

Dengue Fever With Warning Signs

Keywords

dengue; severe dengue; warning sign; plasma leakage; dengue hemorrhagic fever

Outcome Measures

Primary Outcomes (4)

• Host factors & comorbidities

  Association with age, sex, co-morbid condition, care seeking behaviours

  January 01- June 30; 2025

• Laboratory infection markers and immune parameters

  Laboratory biomarkers, immune factor, serotyping

  01/01/2024 to 30/06/2025

• Sociodemographic factors

  Resident, occupation, monthly income, living condition, health-seeking behaviors

  On admission

• Clinical progression parameters during hospitalization

  Clinical sign symptoms during admission and then differences at final outcome, such as on discharge or in death.

  January 01, 2024 to December 31, 2024

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll adults \> over 18 from all four study sites. In addition, children from 1 year to 17 years old will be enrolled at Dhaka North City Corporation Hospital. Any patients complaining of fever between 2-6 days with features suggestive of dengue, such as severe headache, retro-orbital pain, myalgia, arthralgia, transient macular or maculopapular rash, minor hemorrhagic manifestations, (petechiae, ecchymosis, purpura, epistaxis, bleeding gums, haematuria, or a positive tourniquet test), facial flushing or erythema, injected oropharynx, anorexia

You may qualify if:

• Dengue fever with warning signs with Ns1 positive and or IgM positive
• Informed written consent or assent.

You may not qualify if:

• Severe dengue during screening or denied consenting

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (2)

International Centre for Diarrheal Disease Research Bangladesh

Dhaka, 1203, Bangladesh

Location

International Centre for Diarrheal Disease Research Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (8)

• Wang SM, Sekaran SD. Early diagnosis of Dengue infection using a commercial Dengue Duo rapid test kit for the detection of NS1, IGM, and IGG. Am J Trop Med Hyg. 2010 Sep;83(3):690-5. doi: 10.4269/ajtmh.2010.10-0117.

  PMID: 20810840 BACKGROUND

• Guzman MG, Alvarez M, Halstead SB. Secondary infection as a risk factor for dengue hemorrhagic fever/dengue shock syndrome: an historical perspective and role of antibody-dependent enhancement of infection. Arch Virol. 2013 Jul;158(7):1445-59. doi: 10.1007/s00705-013-1645-3. Epub 2013 Mar 8.

  PMID: 23471635 BACKGROUND

• Mustafa MS, Rasotgi V, Jain S, Gupta V. Discovery of fifth serotype of dengue virus (DENV-5): A new public health dilemma in dengue control. Med J Armed Forces India. 2015 Jan;71(1):67-70. doi: 10.1016/j.mjafi.2014.09.011. Epub 2014 Nov 24.

  PMID: 25609867 BACKGROUND

• Changal KH, Raina AH, Raina A, Raina M, Bashir R, Latief M, Mir T, Changal QH. Differentiating secondary from primary dengue using IgG to IgM ratio in early dengue: an observational hospital based clinico-serological study from North India. BMC Infect Dis. 2016 Nov 28;16(1):715. doi: 10.1186/s12879-016-2053-6.

  PMID: 27894268 BACKGROUND

• Vicente CR, Herbinger KH, Froschl G, Malta Romano C, de Souza Areias Cabidelle A, Cerutti Junior C. Serotype influences on dengue severity: a cross-sectional study on 485 confirmed dengue cases in Vitoria, Brazil. BMC Infect Dis. 2016 Jul 8;16:320. doi: 10.1186/s12879-016-1668-y.

  PMID: 27393011 BACKGROUND

• Delli Ponti R, Mutwil M. Structural landscape of the complete genomes of dengue virus serotypes and other viral hemorrhagic fevers. BMC Genomics. 2021 May 17;22(1):352. doi: 10.1186/s12864-021-07638-7.

  PMID: 34000991 BACKGROUND

• Tsheten T, Clements ACA, Gray DJ, Adhikary RK, Furuya-Kanamori L, Wangdi K. Clinical predictors of severe dengue: a systematic review and meta-analysis. Infect Dis Poverty. 2021 Oct 9;10(1):123. doi: 10.1186/s40249-021-00908-2.

  PMID: 34627388 BACKGROUND

• Ng WY, Atan R, Mohd Yunos N, Bin Md Kamal AH, Roslan MH, Quah KY, Teh KX, Zaid M, Kassim M, Mariapun J, Ngim CF, Dhanoa A, Yeo TW. A double whammy: The association between comorbidities and severe dengue among adult patients-A matched case-control study. PLoS One. 2022 Sep 20;17(9):e0273071. doi: 10.1371/journal.pone.0273071. eCollection 2022.

  PMID: 36126060 BACKGROUND

Related Links

• International Centre for Diarrheal Disease Research Bangladesh

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC will be carried out in the CLS hematology lab by a Sysmex hematology analyzer as per the SOP approved by the accredited authority. The clinical Hematology Lab will perform the reference NS1 dengue antigen and IgM-IgG antibody RDT as per their SOP. Molecular serotyping will be conducted at IDD's Emerging Infections \& Parasitology Laboratory. The CDC DENV-1-4 RT-PCR Assay, an in-vitro diagnostic platform, has received approval from the US Food and Drug Administration (FDA) for identifying dengue in individuals exhibiting mild or severe dengue symptoms. The test's primers and probes have been meticulously designed to detect presently circulating strains of DENV-1-4 with a sensitivity comparable to strains found globally.

MeSH Terms

Conditions

Dengue; Severe Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Lubaba Shahrin, MBBS, FCPS

  Scientist, ICDDRB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2024
• Primary Completion: November 13, 2024
• Study Completion: December 30, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)