
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory...
Acute Upper Respiratory Tract InfectionThe study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection
Hepatitis C VirusHCV Infection2 moreHepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An component of grapefruit could block this fat and thus lower the amount of virus in the blood stream. We propose that treatment with this ingredient, called naringenin, could be used to block this fat and HCV in persons infected with hepatitis C.

A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections...
Infections With Soil-Transmitted Helminths (STH)The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection...
Skin InfectionsBacterialThis study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive,...
Gram-positiveSkin Infections2 moreThe purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied topically to uncomplicated skin infections. Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.

A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the...
Helicobacter InfectionsThe proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis. Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.

Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute...
Bacterial InfectionsInfectionThis is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.

Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit...
Pulmonary InfectionsTo evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria causing pulmonary infections in cystic fibrosis patients is similar to those infecting preterm infants. The investigators expect that dornase alfa therapy will improve recovery from ventilator associated pulmonary infections in preterm infants.

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection
Helicobacter InfectionHelicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs. Subjects must have active Helicobacter pylori infection in order to participate in this study.

Oseltamivir Randomised Controlled Efficacy Trial
InfluenzaPneumonia3 moreBackground In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment < 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, to affect household and community transmission rates. Aims and Objectives This proposal aims to compare the duration of clinical illness among patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset. It will compare the duration of viral shedding among all treatment groups vs placebo, risk of transmission to household contacts by treatment group and whether neuraminidase inhibitor use creates resistance. Secondarily it aims to measure the effect on influenza. Design and Methods A double-blind placebo controlled clinical trial design among a population in an urban slum under current influenza disease burden surveillance will be enrolled. Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to < 48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by PCR and a basic reproductive number calculated (R0). Relevance These findings will address whether oseltamivir can affect illness duration and severity, affect transmission, incidence and resistance in high risk urban Asian settings where a pandemic is most likely to arise.