- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02043067
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
2017년 9월 13일 업데이트: University of North Carolina, Chapel Hill
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
연구 개요
상세 설명
Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB.
Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB.
As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care.
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated).
In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.
연구 유형
관찰
등록 (실제)
400
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Lusaka, 잠비아
- Kalingalinga HIV Care and Treatment Clinic
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
16년 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not currently being treated for TB.
설명
Inclusion Criteria:
- Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent
- Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs
- Not have taken any TB treatment in the past 3 months
- Willing to provide locator information and allow study staff to contact by phone or visit them at home if required
Exclusion Criteria:
- Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
new HIV clinic enrollees
All new enrollees to a Lusaka HIV clinic will receive a full TB work-up.
|
All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Prevalence of undiagnosed TB in those with HIV.
기간: Enrollment screening visit
|
Among the cohort of 400 new enrollees at the clinic, all will be tested for TB at the specified time points using enhanced TB screening.
Initial diagnosis will use smear microscopy and culture.
Chest X-ray will be performed on the second day of enrollment.
Presumptive Diagnosis: As culture results will take several days or weeks to become available, a presumptive diagnosis will be made based on history and physical exam, symptoms, smear microscopy and chest radiography results.
All patients who are smear-positive by at least one sample will be diagnosed with TB per national guidelines.
Patients who are smear-negative or suspected of extra-pulmonary TB based on clinical or radiographic findings may be treated empirically for TB at the discretion of a clinical or medical officer.
Sputum samples will also be sent for testing at the end of the study with the Xpert MTB/RIF assay.
|
Enrollment screening visit
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
기간: enrollment, 3, 6, 9 and 12 month visits.
|
To account for patients who are censored prior to 12 months of follow-up, the incidence of TB will be calculated as a rate.
Each patient will contribute follow-up time until they are censored, are diagnosed with TB, or have been in the study for 12 months.
Patients who were diagnosed with TB at enrollment will not be included.
|
enrollment, 3, 6, 9 and 12 month visits.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Performance of diagnostic measures
기간: Days 1, 2, 3; Months 3, 6 9 and 12
|
The performance of symptom screening, light microscopy, fluorescence microscopy, chest x-ray, and Xpert MTB/RIF assay compared to culture of sputum and other fluids in HIV-infected patients will be evaluated using data analysis methods.
|
Days 1, 2, 3; Months 3, 6 9 and 12
|
Cost-effectiveness of each screening/diagnostic tool.
기간: Days 1, 2, 3 and months 3, 6, 9 and 12
|
The primary outcomes of each diagnostic tool (or combination of diagnostic tools) that will be assessed are: cost per case diagnosed/detected, cost per patient cured, cost per case averted.
For instance, the cost per case of active TB detected using the "null" or gold standard screening option will be calculated and compared to the cost per case of active TB detected using each of the other screening options.
|
Days 1, 2, 3 and months 3, 6, 9 and 12
|
Clinical outcomes
기간: up to 12 months post-enrollment
|
Clinical outcomes will be measured in a cohort of HIV-infected patients and TB/HIV co-infected patients during the first 12 months of HIV care including but not limited to mortality, immune recovery and development of other opportunistic infections.
|
up to 12 months post-enrollment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Stewart Reid, MD, CIDRZ; University of North Carolina at Chapel Hill
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Meintjes G, Lawn SD, Scano F, Maartens G, French MA, Worodria W, Elliott JH, Murdoch D, Wilkinson RJ, Seyler C, John L, van der Loeff MS, Reiss P, Lynen L, Janoff EN, Gilks C, Colebunders R; International Network for the Study of HIV-associated IRIS. Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings. Lancet Infect Dis. 2008 Aug;8(8):516-23. doi: 10.1016/S1473-3099(08)70184-1.
- Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
- Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0. Erratum In: Lancet 1999 May 15;353(9165):1714.
- Wood R, Middelkoop K, Myer L, Grant AD, Whitelaw A, Lawn SD, Kaplan G, Huebner R, McIntyre J, Bekker LG. Undiagnosed tuberculosis in a community with high HIV prevalence: implications for tuberculosis control. Am J Respir Crit Care Med. 2007 Jan 1;175(1):87-93. doi: 10.1164/rccm.200606-759OC. Epub 2006 Sep 14.
- Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, Huang L, Caceres T, Mehdiyev R, Raymond L, Whitelaw A, Sagadevan K, Alexander H, Albert H, Cobelens F, Cox H, Alland D, Perkins MD. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011 Apr 30;377(9776):1495-505. doi: 10.1016/S0140-6736(11)60438-8. Epub 2011 Apr 18.
- Steingart KR, Henry M, Ng V, Hopewell PC, Ramsay A, Cunningham J, Urbanczik R, Perkins M, Aziz MA, Pai M. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis. 2006 Sep;6(9):570-81. doi: 10.1016/S1473-3099(06)70578-3. Erratum In: Lancet Infect Dis. 2006 Oct;6(10):628.
- Harris JB, Hatwiinda SM, Randels KM, Chi BH, Kancheya NG, Jham MA, Samungole KV, Tambatamba BC, Cantrell RA, Levy JW, Kimerling ME, Reid SE. Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Jul;12(7):773-9.
- Moore D, Liechty C, Ekwaru P, Were W, Mwima G, Solberg P, Rutherford G, Mermin J. Prevalence, incidence and mortality associated with tuberculosis in HIV-infected patients initiating antiretroviral therapy in rural Uganda. AIDS. 2007 Mar 30;21(6):713-9. doi: 10.1097/QAD.0b013e328013f632.
- Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis. 2004 Jun;8(6):792-5.
- Day JH, Charalambous S, Fielding KL, Hayes RJ, Churchyard GJ, Grant AD. Screening for tuberculosis prior to isoniazid preventive therapy among HIV-infected gold miners in South Africa. Int J Tuberc Lung Dis. 2006 May;10(5):523-9.
- Lawn SD, Myer L, Bekker LG, Wood R. Burden of tuberculosis in an antiretroviral treatment programme in sub-Saharan Africa: impact on treatment outcomes and implications for tuberculosis control. AIDS. 2006 Aug 1;20(12):1605-12. doi: 10.1097/01.aids.0000238406.93249.cd.
- Wise J. Southern Africa is moving swiftly to combat the threat of XDR-TB. Bull World Health Organ. 2006 Dec;84(12):924-5. No abstract available.
- Hernandez-Garduno E, Cook V, Kunimoto D, Elwood RK, Black WA, FitzGerald JM. Transmission of tuberculosis from smear negative patients: a molecular epidemiology study. Thorax. 2004 Apr;59(4):286-90. doi: 10.1136/thx.2003.011759.
- Kimerling ME, Schuchter J, Chanthol E, Kunthy T, Stuer F, Glaziou P, Ee O. Prevalence of pulmonary tuberculosis among HIV-infected persons in a home care program in Phnom Penh, Cambodia. Int J Tuberc Lung Dis. 2002 Nov;6(11):988-94.
- Ba F, Rieder HL. A comparison of fluorescence microscopy with the Ziehl-Neelsen technique in the examination of sputum for acid-fast bacilli. Int J Tuberc Lung Dis. 1999 Dec;3(12):1101-5.
- Mugusi F, Villamor E, Urassa W, Saathoff E, Bosch RJ, Fawzi WW. HIV co-infection, CD4 cell counts and clinical correlates of bacillary density in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2006 Jun;10(6):663-9.
- Siddiqi K, Lambert ML, Walley J. Clinical diagnosis of smear-negative pulmonary tuberculosis in low-income countries: the current evidence. Lancet Infect Dis. 2003 May;3(5):288-96. doi: 10.1016/s1473-3099(03)00609-1.
- Bakari M, Arbeit RD, Mtei L, Lyimo J, Waddell R, Matee M, Cole BF, Tvaroha S, Horsburgh CR, Soini H, Pallangyo K, von Reyn CF. Basis for treatment of tuberculosis among HIV-infected patients in Tanzania: the role of chest x-ray and sputum culture. BMC Infect Dis. 2008 Mar 6;8:32. doi: 10.1186/1471-2334-8-32.
- Swaminathan S, Paramasivan CN, Kumar SR, Mohan V, Venkatesan P. Unrecognised tuberculosis in HIV-infected patients: sputum culture is a useful tool. Int J Tuberc Lung Dis. 2004 Jul;8(7):896-8.
- Stringer JS, Zulu I, Levy J, Stringer EM, Mwango A, Chi BH, Mtonga V, Reid S, Cantrell RA, Bulterys M, Saag MS, Marlink RG, Mwinga A, Ellerbrock TV, Sinkala M. Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes. JAMA. 2006 Aug 16;296(7):782-93. doi: 10.1001/jama.296.7.782.
- Ministry of Health, Human Resources for Health: Strategic Plan 2006-2010. Ministry of Health, Ndeke House, Lusaka. 2006.
- Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S, Dawson R, Whitelaw A, Hoelscher M, Sharma S, Pai M, Warren R, Dheda K. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011 Jul 1;184(1):132-40. doi: 10.1164/rccm.201101-0056OC. Epub 2011 Apr 14.
- Lawn SD, Bekker LG, Miller RF. Immune reconstitution disease associated with mycobacterial infections in HIV-infected individuals receiving antiretrovirals. Lancet Infect Dis. 2005 Jun;5(6):361-73. doi: 10.1016/S1473-3099(05)70140-7.
- Colebunders R, John L, Huyst V, Kambugu A, Scano F, Lynen L. Tuberculosis immune reconstitution inflammatory syndrome in countries with limited resources. Int J Tuberc Lung Dis. 2006 Sep;10(9):946-53.
- Lawn SD, Wilkinson RJ, Lipman MC, Wood R. Immune reconstitution and "unmasking" of tuberculosis during antiretroviral therapy. Am J Respir Crit Care Med. 2008 Apr 1;177(7):680-5. doi: 10.1164/rccm.200709-1311PP. Epub 2008 Jan 17.
- Francis J. Curry National Tuberculosis Center Institutional Consultation Services, Conducting Sputum Induction Safely. 1999.
- Dasgupta K, Menzies D. Cost-effectiveness of tuberculosis control strategies among immigrants and refugees. Eur Respir J. 2005 Jun;25(6):1107-16. doi: 10.1183/09031936.05.00074004.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 10월 1일
기본 완료 (실제)
2012년 9월 1일
연구 완료 (실제)
2013년 5월 1일
연구 등록 날짜
최초 제출
2014년 1월 16일
QC 기준을 충족하는 최초 제출
2014년 1월 20일
처음 게시됨 (추정)
2014년 1월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 13일
마지막으로 확인됨
2014년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CIDRZ 1226/IRB12-0416
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
결핵에 대한 임상 시험
-
François SpertiniUniversity of Oxford완전한
-
Assistance Publique - Hôpitaux de Paris완전한
Comprehensive TB screening에 대한 임상 시험
-
Assistance Publique - Hôpitaux de Paris완전한
-
Yale UniversityNational Institutes of Health (NIH)아직 모집하지 않음
-
NanoPin Technologies, Inc.Fortrea아직 모집하지 않음결핵, 폐 | 결핵, 폐외 | 결핵 활성
-
Oncurious NVBeat Childhood Cancer완전한재발성 또는 불응성 수모세포종(MB), 신경모세포종(NB), 유잉 육종(ES) 및 폐포 횡문근육종(ARMS)미국
-
Foundation for Innovative New Diagnostics, SwitzerlandLudwig-Maximilians - University of Munich; Ifakara Health Institute; Centro de Investigação... 그리고 다른 협력자들모집하지 않고 적극적으로
-
Centers for Disease Control and PreventionUnited States President's Emergency Plan for AIDS Relief완전한