Additive Benefit of the Urine LAM Test to Current TB Diagnostics in HIV Positive Adults in Panama City, Panama

NCT02911740 | Withdrawn

• 1 other identifier: IRB201600869
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013, there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia. In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management, which in turn results in unnecessary toxicity, antibiotic resistance, and monetary expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a simple urine dipstick test and evaluating physician response to new diagnostic testing, in order to reduce misdiagnosis and improve health outcomes in the HIV population.

Conditions

Tuberculosis; HIV; Histoplasmosis

Outcome Measures

Primary Outcomes (2)

• Dual therapy duration

  The number of days that anti-histoplasmosis and anti-tubercular medications are co-administered

  1 Week

• Physician questionnaire

  The questionnaire will be measured by Physician responses of Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree.

  1 year

Secondary Outcomes (3)

• Creatinine change during hospitalization

  1 week

• Number of diagnostic tests performed during hospitalization

  1 week

• Mortality during hospital stay

  1 week

Study Arms (2)

Urine LAM Ag test

EXPERIMENTAL

Patients will be enrolled prospectively and tested for TB using the urine LAM Ag test

Other: Urine LAM Ag test

Retrospective arm

NO INTERVENTION

Charts of retrospectively selected patients from the Hospital Santo Tomas database who presented within the last five years meeting inclusion criteria will be used as controls

Interventions

Urine LAM Ag test OTHER

TB diagnostic assay

Urine LAM Ag test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive adult, and
• Admitted to Hospital Santo Tomas, and
• history of fevers, and
• Two or more of the following symptoms:
• cough
• shortness of breath
• night sweats
• weight loss
• fatigue
• loss of appetite

You may not qualify if:

• Under 18 yrs of age, or
• Already on TB therapy, or
• Anuric

Sponsors & Collaborators

• University of Florida: lead
• Hospital Santo Tomas: collaborator

Related Publications (8)

• Gutierrez ME, Canton A, Sosa N, Puga E, Talavera L. Disseminated histoplasmosis in patients with AIDS in Panama: a review of 104 cases. Clin Infect Dis. 2005 Apr 15;40(8):1199-202. doi: 10.1086/428842. Epub 2005 Mar 2.

  PMID: 15791523 BACKGROUND

• Colombo AL, Tobon A, Restrepo A, Queiroz-Telles F, Nucci M. Epidemiology of endemic systemic fungal infections in Latin America. Med Mycol. 2011 Nov;49(8):785-98. doi: 10.3109/13693786.2011.577821. Epub 2011 May 4.

  PMID: 21539506 BACKGROUND

• Vittor AY, Garland JM, Schlossberg D. Improving the diagnosis of tuberculosis: From QuantiFERON to new techniques to diagnose tuberculosis infections. Curr HIV/AIDS Rep. 2011 Sep;8(3):153-63. doi: 10.1007/s11904-011-0083-7.

  PMID: 21660459 BACKGROUND

• Van Rie A, Page-Shipp L, Hanrahan CF, Schnippel K, Dansey H, Bassett J, Clouse K, Scott L, Stevens W, Sanne I. Point-of-care Xpert(R) MTB/RIF for smear-negative tuberculosis suspects at a primary care clinic in South Africa. Int J Tuberc Lung Dis. 2013 Mar;17(3):368-72. doi: 10.5588/ijtld.12.0392.

  PMID: 23407225 BACKGROUND

• Lawn SD. Point-of-care detection of lipoarabinomannan (LAM) in urine for diagnosis of HIV-associated tuberculosis: a state of the art review. BMC Infect Dis. 2012 Apr 26;12:103. doi: 10.1186/1471-2334-12-103.

  PMID: 22536883 BACKGROUND

• Wheat LJ, Connolly-Stringfield PA, Baker RL, Curfman MF, Eads ME, Israel KS, Norris SA, Webb DH, Zeckel ML. Disseminated histoplasmosis in the acquired immune deficiency syndrome: clinical findings, diagnosis and treatment, and review of the literature. Medicine (Baltimore). 1990 Nov;69(6):361-74. doi: 10.1097/00005792-199011000-00004.

  PMID: 2233233 BACKGROUND

• Laurence YV, Griffiths UK, Vassall A. Costs to Health Services and the Patient of Treating Tuberculosis: A Systematic Literature Review. Pharmacoeconomics. 2015 Sep;33(9):939-55. doi: 10.1007/s40273-015-0279-6.

  PMID: 25939501 BACKGROUND

• Rudolf F, Joaquim LC, Vieira C, Bjerregaard-Andersen M, Andersen A, Erlandsen M, Sodemann M, Andersen PL, Wejse C. The Bandim tuberculosis score: reliability and comparison with the Karnofsky performance score. Scand J Infect Dis. 2013 Apr;45(4):256-64. doi: 10.3109/00365548.2012.731077. Epub 2012 Oct 31.

  PMID: 23113626 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Histoplasmosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Mycoses

Study Officials

• Amy Y Vittor, MD PHD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 26, 2017

Record last verified: 2017-12