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Itabangi H, Ampaire L, Njovu IK, Nalumaga PP, Musinguzi B, Kassaza K, Kiguli JM, Bazira J, Mwesigye J, Iramiot JS, Baguma A, Kabanda T, Bongomin F, Kwizera R, Achan B, Cox MJ, King J, May R, Ballou E
Investigating Metabolic and Molecular Ecological Evolution of Opportunistic Pulmonary Fungal Coinfections: Protocol for a Laboratory-Based Cross-Sectional Study
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Characterization of fungal-bacterial co-infections among presumptive pulmonary tuberculosis cases in Western Uganda, a project protocol.
Herbert Itabangi;
Lucas Ampaire;
Israel Kizza Njovu;
Pauline Petra Nalumaga;
Benson Musinguzi;
Kennedy Kassaza;
James Mukasa Kiguli;
Joel Bazira;
James Mwesigye;
Jacob Stanley Iramiot;
Andrew Baguma;
Tasera Kabanda;
Felix Bongomin;
Richard Kwizera;
Beatrice Achan;
Mike. J. Cox;
Jason King;
Robin.C. May;
Elizabeth Ballou
ABSTRACT
Background:
Fungal-bacterial co-colonization and co-infections is an emerging challenge among patients with pulmonary tuberculosis (PTB), yet the underlying pathogenic mechanisms and microbiome interactions are poorly understood. Understanding how environmental microbes such as fungi and bacteria co-evolve and develop traits to evade host immune responses, and resist treatment is critical to controlling opportunistic co-infections.
Objective:
This is a protocol for a study aimed at determining and characterizing the burden, etiological profiles, microbial communities, and interaction relationships established between fungi and bacteria as implicated in co-infections in patients with presumptive PTB.
Methods:
This will be a laboratory-based cross-sectional study, with a sample size of 406 participants. From each participant, two sputum (an on-spot and early morning) samples will be collected. We will also collect baseline data including, demographic and clinical history using a patient-reported questionnaire. This will be a diagnosis-based observational study. The primary outcome will be the overall diagnostic profile of the study participants. Diagnostic factors associated with the etiological profile will also be analyzed in univariate and multivariate. Odds ratios with 95% confidence intervals (CIs) will be presented with a statistical significance at p<0.0.5.
Results:
The study has been approved by the Mbarara University Research Ethic Committee (MUREC1/7-07/09/20) and the Uganda National Council of Science and Technology (HS1233ES). Following careful scrutiny, the protocol was designed to enable patient enrollment which began in March 2022 at Mbarara University Teaching Hospital. Data collection is expected to be completed by July 2023, manuscripts submitted for publication thereafter.
Conclusions:
Through this protocol, we shall explore the metabolic and molecular ecological evolution of opportunistic pulmonary fungal co-infection among presumptive PTB cases. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN) registry (Ref: ISRCTN33572982).
Citation
Please cite as:
Itabangi H, Ampaire L, Njovu IK, Nalumaga PP, Musinguzi B, Kassaza K, Kiguli JM, Bazira J, Mwesigye J, Iramiot JS, Baguma A, Kabanda T, Bongomin F, Kwizera R, Achan B, Cox MJ, King J, May R, Ballou E
Investigating Metabolic and Molecular Ecological Evolution of Opportunistic Pulmonary Fungal Coinfections: Protocol for a Laboratory-Based Cross-Sectional Study