Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04545164
Other study ID # 17799
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date May 26, 2022

Study information

Verified date May 2022
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

People living with HIV (PLHIV) who require admission to hospital in WHO Africa region have poor outcomes. TB is very common in this group, but can be difficult to diagnose. The CASTLE trial aims to determine whether systematic screening for tuberculosis using digital chest X-ray with computer-aided diagnosis (DCXR-CAD) plus urine lipoarabinomannan testing with Fujifilm SILVAMP TB LAM (FujiLAM) plus usual care can improve admission outcomes for hospitalised PLHIV, compared to usual care alone. Our study is a single centre, unblinded, cluster-randomised (by day of admission) trial of DCXR-CAD plus FujiLAM plus usual care vs. usual care alone for screening for TB in unselected adult PLHIV admitted to a district general hospital in Malawi. The primary outcome is the proportion of people starting TB treatment by the time of death or hospital discharge. The secondary outcomes are all-cause mortality at 56 days from enrolment, proportion of people starting TB treatment within 24 hours from enrolment, and proportion of people with undiagnosed TB. In the CASTLE study we collect a single sputum sample for M. tb culture from participants and undiagnosed TB specifically refers to a person who did not start TB treatment by the time of death or discharge from hospital and has a M. tb cultured from their sputum sample. Alongside the two trial arms, a third smaller diagnostic cohort arm (1 in 9 of admission days / trial clusters) will explore the range of underlying infectious pathology. The diagnostic cohort does not contribute to trial outcomes.


Description:

CASTLE is funded by Wellcome, grant reference 203905/Z/16/Z


Recruitment information / eligibility

Status Completed
Enrollment 498
Est. completion date May 26, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Requires acute admission to a hospital medical ward at Zomba Central Hospital for any reason - Is living with HIV (existing or new diagnosis, irrespective of ART status) - Willing and able to give informed consent Exclusion Criteria: - Aged <18 years - Has been admitted to a medical ward for longer than 18 hours - Taking TB treatment before admission or has received treatment for TB within the preceding 6 months. - Has already been in the study during an earlier hospital admission.

Study Design


Intervention

Diagnostic Test:
CAD4TB
CAD4TB is a Computer Aided Diagnosis (CAD) image processing algorithm that can aid interpretation of Chest X-ray images to accurately detect tuberculosis.
FujiLAM
Fujifilm SILVAMP TB LAM is a high sensitivity test for mycobacterial lipoarabinomannan (LAM) in urine samples.

Locations

Country Name City State
Malawi Zomba Central Hospital Zomba

Sponsors (4)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Kamuzu University of Health Sciences, Liverpool School of Tropical Medicine, Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Country where clinical trial is conducted

Malawi, 

References & Publications (1)

Burke RM, Nyirenda S, Twabi HH, Nliwasa M, Joekes E, Walker N, Nyirenda R, Gupta-Wright A, Fielding K, MacPherson P, Corbett EL. Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study). PLoS One. 2022 Jan 10;17(1):e0261877. doi: 10.1371/journal.pone.0261877. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Mortality (measured as a proportion) Proportion of people dying by 56 days from enrolment. 56 days from enrolment
Other Inpatient mortality Proportion of people dying prior to hospital discharge Censored at 56 days for those who are still alive and admitted to hospital at 56 days from enrolment.
Other Confirmed TB The proportion of TB diagnoses that are microbiologically confirmed vs. clinically diagnosed without microbiological confirmation. From time of enrolment into trial to time of discharge from hospital or death (whichever is earlier)
Other Intervention fidelity Proportion of people randomised to DCXR-CAD plus FujiLAM who have a valid CxR and CAD score recorded, and a FujiLAM result. 24 hours from enrolment
Other Diagnostic accuracy of DCXR-CAD Sensitivity, specificity, positive and negative predictor value compared to a composite microbiological gold standard. From time of enrolment into trial to time of discharge from hospital or death (whichever is earlier)
Other Prevalence of infectious disease (enhanced diagnostic cohort) To describe the proportion of patients meeting a clinical or clinical / microbiological description for the following: Sepsis; Invasive bacterial disease; Cryptococcal disease; Pneumocystis jirovecci pneumonia; Bacterial pneumonia; Immune reconstitution inflammatory syndrome (IRIS); HIV treatment failure From time of enrolment into trial to time of discharge from hospital or death (whichever is earlier)
Primary TB treatment initiation Proportion of participants started on TB treatment From time of enrolment into trial to time of discharge from hospital or death (whichever is earlier)
Secondary Mortality Time (in days) to death from any case. Censored at 56 days from enrolment
Secondary Undiagnosed TB Positive sputum culture for mycobacterium tuberculosis at reference lab and participant is not on TB treatment at time of hospital discharge or death. From time of enrolment into trial to time of discharge from hospital or death (whichever is earlier)
Secondary Same day TB treatment Proportion of people starting TB treatment within 24 hours of enrollment 24 hours from enrolment
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2