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Communicable Diseases clinical trials

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NCT ID: NCT05979207 Completed - Inflammation Clinical Trials

Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum

Start date: August 1, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP). Up to 18 participants will be enrolled in cohorts of up to 6 participants each. The study will proceed as follows for all participants: - Screening period of up to 28 days to recruit healthy adult participants. - Day 0: Intravenous inoculation with approximately 2,800 viable P. falciparum-infected red blood cells. - Days 1-3: Daily follow up via phone call or text message. - Days 4-7: Daily site visits for clinical evaluation and blood sampling to monitor malaria parasite numbers via quantitative polymerase chain reaction (qPCR). - Day 7 PM: Start of confinement within the clinical trial unit. - Day 8: Administration of a single oral dose of the IMP (MMV367). Different doses of MMV367 will be administered across and within cohorts in order to effectively characterise the PK/PD relationship. - Days 8-11: Regular clinical evaluation and blood sampling while confined to monitor malaria parasite numbers and measure MMV367 plasma concentration. - Day 11 AM: End of confinement within clinical trial unit. - Days 12-23: Outpatient follow-up for clinical evaluation and blood sampling. - Day 24: Initiation of compulsory definitive antimalarial treatment with Riamet® (artemether/lumefantrine) and/or other registered antimalarials if required. Treatment will be initiated earlier than Day 24 in the event of: - Insufficient parasite clearance following IMP dosing - Parasite regrowth following IMP dosing Characterising the pharmacokinetic/pharmacodynamic relationship of MMV367 - Participant discontinuation/withdrawal, - Investigator's discretion in the interest of participant safety. - Day 27: End of study visit for final clinical evaluation and to ensure complete clearance of malaria parasites.

NCT ID: NCT05970744 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years

Start date: May 10, 2023
Phase: Phase 1
Study type: Interventional

The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years.

NCT ID: NCT05959928 Completed - COVID-19 Clinical Trials

Continuous Temperature Telemonitoring of Patients With COVID-19 and Other Infectious Diseases in Hospital at Home Using Viture

Viture
Start date: February 9, 2021
Phase:
Study type: Observational

The aim of this cohort study is to validate Viture®, a continuous temperature telemonitoring system, evaluating the level of agreement with a standard commercially available digital axillary thermometer. The study also aims to evaluate the safety and comfort of the system and to evaluate the impact that the introduction of Viture has on the health care practice of a HaH unit. Furthermore, the advantages of Viture compared to the standard method will be evaluated.

NCT ID: NCT05952921 Completed - Clinical trials for Periodontal Diseases

Comparison of the Effectiveness of Hypochlorous Acid and Chlorhexidine as a Post-surgical Antimicrobial Agent

HOCl-Post-AA
Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effectiveness of Hypochlorous Acid and Chlorhexidine as postsurgical antimicrobial agents in the treatment of severe chronic periodontal disease. The selected patients will be randomly divided into two groups of 16 each. Subjects in group I will undergo scaling and surgical root planing and will use mouthrinse with 0.05% HOCl for 7 days, after this they will mouthwash with 0.025% HOCl until day 21 and Subjects in group II will undergo scaling and surgical root planing followed by a rinse with CHX 0.2% for 7 days, after this they will mouthwash with 0.12% CHX until day 21. Null Hypothesis: There are no significant differences between hypochlorous acid and chlorhexidine in reducing plaque formation at 7, 21 and 90 days of evaluation. There are no significant differences between HOCl and CHX in the elimination or reduction of periodontopathogenic microorganisms at 7, 21 and 90 days. Alternative hypotheses: There are significant differences between hypochlorous acid and chlorhexidine in reducing plaque formation at 7, 21 and 90 days of evaluation. There are significant differences between HOCl and CHX in the elimination or reduction of periodontopathogenic microorganisms at 7, 21 and 90 days.

NCT ID: NCT05951504 Completed - Clinical trials for Odontogenic Infection of Jaw (Disorder)

The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin

Start date: June 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a clinical trial. In Manitoba, the treatment of cervicofacial infections of odontogenic origin which require inpatient medical and surgical management by Oral and Maxillofacial Surgeons are treated in a reproducible and stepwise manner. After a standardized pre-operative diagnostic workup (including appropriate imaging, bloodwork, and pre-operative history and physical), these patients are taken to the operating room for appropriate surgical intervention (extraction of necessary teeth and incision/drainage of the associated abscess). These patients are then treated with a combination of antibiotics, steroids, and adjunctive medications as needed for supportive care until ready for discharge. Intravenous corticosteroids are frequently administered following dentoalveolar and maxillofacial surgery procedures to decrease post-operative edema, improve patient comfort, and thus hasten recovery time. Within the context of primary and deep space odontogenic infections, one of the major sources of morbidity is the mass effect produced by edema causing airway obstruction. Additionally, manipulation of the soft tissues during the surgical procedure(s) (incision and drainage, extraction of teeth, etc.) may result in increased swelling around the airway. Inflammation and spasm of the muscles of mastication is another sequelae of infection, which can result in severe trismus. The literature supports the use of intravenous corticosteroids as an adjunctive treatment in the management of primary and deep space neck infections, and thus corticosteroid use is within the standard of care. However, the glucocorticoid dosing regimen is currently determined by the clinical judgment of the attending surgeon. One commonly used regimen for steroid dosing is prescribing Solumedrol 125mg IV X1 dose at the time of surgery. Another commonly used regimen for steroid dosing is prescribing Solumedrol 125mg IV X1 dose at the time of surgery, followed by 3 consecutive doses of Solumedrol 125mg IV every 6 hours post-operatively. The goal of this study is to guide future decisions related to the treatment of patients with cervicofacial infections of odontogenic origin in Manitoba. This study is intended to follow the post-operative inpatient course of 30 patients with various cervicofacial infections of odontogenic origin. All will be treated via a standardized surgical protocol (incision/drainage and extraction of necessary teeth), antibiotics, and steroids. 15 patients will be randomly assigned to receive 1 dose of Solumedrol 125mg IV at the time of surgery but no doses following surgery. The remaining 15 patients will receive 1 dose of Solumedrol 125mg IV at the time of surgery plus 3 consecutive doses of Solumedrol 125mg IV every 6 hours post-operatively. In summary, the only impact of study involvement will be the determination of the intravenous glucocorticoid dosing schedule, as all patients will continue to receive the current standard of care (including surgical management, antibiotics, and intravenous corticosteroids). To ensure the preservation of the highest level of patient care, in the rare instance where an attending surgeon decides peri-operatively that the pre-determined steroid dosing regimen will result in unsatisfactory treatment, the randomized patient assignment will be abandoned, and alternative treatment regimens will be used under the guidance of the attending Oral and Maxillofacial Surgeon. Treatment will be undertaken at the Health Sciences Centre adult operating room and inpatient wards, the primary operating site for the University of Manitoba's attending on-call Oral and Maxillofacial Surgeons. The patient's post-operative course in hospital will be completed within the inpatient wards at the Health Sciences Centre, until the patients are deemed appropriate for discharge. Specific patient outcomes will be evaluated at the time of hospital admission, daily while admitted to hospital, and at the time of hospital discharge. Outcomes evaluated will include: - C reactive protein (CRP) levels (acute phase reactant which is a hematologic biomarker of inflammation) - White blood cell (WBC) levels (hematologic biomarker of infection) - Length of hospital admission (days) - Trismus (in mm) - Daily clinical examination findings (during morning inpatient rounds while admitted) This study poses no additional risks to the patients involved, as these patients would be receiving intravenous glucocorticoids whether they were enrolled in the study or not. There are standard risks of complications involved with both the surgical and pharmaceutical treatment of cervicofacial infections of odontogenic origin, and these risks are discussed with patients pre-operatively and prior to hospital admission to obtain informed written consent.

NCT ID: NCT05945498 Completed - Clinical trials for Tuberculosis Infection

Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years

Start date: May 10, 2023
Phase: Phase 1
Study type: Interventional

The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years.

NCT ID: NCT05933408 Completed - Clinical trials for Colorectal (Colon or Rectal) Cancer

TREM-1 - a New Marker of Serious Infectious Complications in Colorectal Surgery?

Start date: November 1, 2018
Phase:
Study type: Observational

The aim of this study is to investigate the potential use of soluble TREM-1 (sTREM-1) to predict serious infectious complications in patients undergoing laparoscopic colorectal surgery. Patients with colon or rectal cancer, who underwent elective laparoscopic colorectal cancer surgery between November 2018 and February 2020 were included into study. Blood samples for the TREM-1 protein assay were collected from each patient four times: preoperatively and on three following postoperative days (PODs). Patients with infectious complications who formed group 1, were matched 1:1 with patients without complications (group 2). Case-matched analysis was performed by selecting patients for the control group from the group of patients paired by age, ASA scale, stage of cancer and type of surgery.

NCT ID: NCT05932823 Completed - Clinical trials for Hip Prosthesis Infection

Does the Type of Ventilation Affect the Risk for Infections After Hip Replacements?

Start date: January 1, 2010
Phase:
Study type: Observational [Patient Registry]

Background: During hip replacement surgery, there is a risk that bacteria in the operating room can cause an infection. To try and reduce this risk, some operating rooms use a special system called laminar airflow (LAF), which reduces the number of bacteria in the air. However, it's not clear if LAF is better than the older system, called turbulent airflow (TAF), for preventing infections. Aim: The aim of this study is to compare the two airflow systems and see if LAF is better at preventing infections after hip replacement surgery. Methods: Information from a database containing all hip replacement surgeries done in Denmark between 2010 and 2020 is examined. The number of infections that occur in surgeries done with LAF, which reduces the number of bacteria in the air during surgery, is compared to the number of infections that occur in surgeries done with TAF. To make the results more credible, the data from the hip register was combined with data from the bacterial cultures taken during surgery. Use and relevance: Infections after hip replacement surgery can be very serious and expensive to treat. Hospitals need to choose the best airflow system to help prevent these infections. This study is important because it gives more accurate information about which system is better at preventing infections and can help hospitals make better choices when they are designing or renovating operating rooms.

NCT ID: NCT05919966 Completed - Clinical trials for Central Line-associated Bloodstream Infection (CLABSI)

The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units

Start date: April 12, 2023
Phase:
Study type: Observational

We conducted a retrospective observational cohort study assessing the relationship between regular bathing using 2% CHG wipes every other day and the occurrence of central line-associated infections (CLABSI) in patients within the medical intensive care unit (MICU).

NCT ID: NCT05919888 Completed - Surgery Clinical Trials

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

Start date: June 26, 2023
Phase: Phase 4
Study type: Interventional

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.