Protocol for studying cough frequency in people with pulmonary tuberculosis.
Cough is a key symptom of tuberculosis (TB) as well as the main cause of transmission. However, a recent literature review found that cough frequency (number of coughs per hour) in patients with TB has only been studied once, in 1969. The main aim of this study is to describe cough frequency patterns before and after the start of TB treatment and to determine baseline factors that affect cough frequency in these patients. Secondarily, we will evaluate the correlation between cough frequency and TB microbiological resolution.



This study will select participants with culture confirmed TB from 2 tertiary hospitals in Lima, Peru. We estimated that a sample size of 107 patients was sufficient to detect clinically significant changes in cough frequency. Participants will initially be evaluated through questionnaires, radiology, microscopic observation drug susceptibility broth TB-culture, auramine smear microscopy and cough recordings. This cohort will be followed for the initial 60 days of anti-TB treatment, and throughout the study several microbiological samples as well as 24 h recordings will be collected. We will describe the variability of cough episodes and determine its association with baseline laboratory parameters of pulmonary TB. In addition, we will analyse the reduction of cough frequency in predicting TB cure, adjusted for potential confounders.



Ethical approval has been obtained from the ethics committees at each participating hospital in Lima, Peru, Asociación Benéfica PRISMA in Lima, Peru, the Universidad Peruana Cayetano Heredia in Lima, Peru and Johns Hopkins University in Baltimore, USA. We aim to publish and disseminate our findings in peer-reviewed journals. We also expect to create and maintain an online repository for TB cough sounds as well as the statistical analysis employed.
Facultad de Medicina 'Alberto Hurtado', Universidad Peruana Cayetano Heredia, Lima, Perú
Alvaro
0000-0002-4057-7686
A
Proaño
Asociación Benéfica PRISMA, Lima, Perú Department of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA Innovation For Health And Development (IFHAD), Laboratory of Research and Development, Universidad Peruana Cayetano Heredia, Lima, Peru.
Marjory A
MA
Bravard
Department of Electrical and Computer Engineering, Tufts University, Medford, Massachusetts, USA.
Brian H
BH
Tracey
Instituto Nacional de Salud del Niño San Borja, Lima, Perú Laboratorio de Bioinformática y Biología Molecular, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú
José W
JW
López
Department of Global Community Health and Behavioral Sciences, Tulane University, New Orleans, Louisiana, USA Escuela Profesional de Ingeniería Física, Facultad de Ciencias, Universidad Nacional de Ingeniería, Lima, Perú
German
G
Comina
Laboratorio de Bioinformática y Biología Molecular, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú Laboratorio de Investigación en Enfermedades Infecciosas, Laboratorio de Investigación y Desarrollo, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú
Mirko
M
Zimic
Laboratorio de Investigación en Enfermedades Infecciosas, Laboratorio de Investigación y Desarrollo, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú
Jorge
J
Coronel
Department of Global Community Health and Behavioral Sciences, Tulane University, New Orleans, Louisiana, USA.
Gwenyth O'Neil
GO
Lee
Laboratorio de Investigación en Enfermedades Infecciosas, Laboratorio de Investigación y Desarrollo, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú
Luz
L
Caviedes
Servicio de Neumología, Hospital Nacional Alcides Carrión, Lima, Perú
Jose Luis
JL
Cabrera
Servicio de Neumología, Hospital Nacional Dos de Mayo, Lima, Perú
Antonio
A
Salas
Facultad de Medicina, Universidad Nacional Mayor de San Marcos, Lima, Perú Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo, Lima, Perú
Eduardo
E
Ticona
Infectious Diseases & Immunity, Imperial College London, London, UK.
Daniela E
DE
Kirwan
Infectious Diseases & Immunity, Imperial College London, London, UK Wellcome Trust Imperial College Centre for Global Health Research, London, UK.
Jon S
JS
Friedland
Innovation For Health And Development (IFHAD), Laboratory of Research and Development, Universidad Peruana Cayetano Heredia, Lima, Peru Infectious Diseases & Immunity, Imperial College London, London, UK Wellcome Trust Imperial College Centre for Global Health Research, London, UK.
Carlton A
CA
Evans
Asociación Benéfica PRISMA, Lima, Perú Laboratorio de Investigación en Enfermedades Infecciosas, Laboratorio de Investigación y Desarrollo, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
David A
DA
Moore
Asociación Benéfica PRISMA, Lima, Perú Laboratorio de Investigación en Enfermedades Infecciosas, Laboratorio de Investigación y Desarrollo, Facultad de Ciencias y Filosofía, Universidad Peruana Cayetano Heredia, Lima, Perú Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
Robert H
RH
Gilman
D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D003371:Cough / Q000382:microbiology / Q000503:physiopathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis; D010568:Peru; D011237:Predictive Value of Tests; D011446:Prospective Studies; D014397:Tuberculosis, Pulmonary / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology*
D000995:Antitubercular Agents
Cough; Monitoring