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NCT ID: NCT03251196 Active, not recruiting - Clinical trials for Respiratory Tract Infections

TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB

TBSEQUEL
Start date: September 22, 2017
Phase:
Study type: Observational [Patient Registry]

This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled at the time of TB diagnosis and prospectively followed for at least two years after TB-treatment initiation with optional prolonged follow-up. Study visits will be performed in the study clinics or if necessary at the participant's home at pre-defined time points after TB treatment initiation. Clinical assessments, biological sample collections and collection of socio-economic data will be performed according to the pre-defined schedule of events.

NCT ID: NCT03245398 Completed - Hookworm Clinical Trials

Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children

Start date: July 25, 2017
Phase: Phase 4
Study type: Interventional

This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of two regimens of mebendazole in school-aged children. Thus, our primary objective is to assess the efficacy and safety of: i) 100 mg solid tablets twice a day for 3 days, and ii) one dose of 500 mg solid tablets of mebendazole in participants aged 6-12, inclusive, infected with hookworm. The primary endpoint of the trial is the cure rate (CR) of the 3-day regimen of mebendazole against hookworm and a single dose mebendazole treatment. The secondary objectives are to determine if the multi-dose regimen is superior to the single dose regimen, evaluate the efficacy against concomitant soil-transmitted helminth infections, and assess the safety of both mebendazole regimens. After obtaining informed consent from children's caregiver, the medical history of the participating individuals will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Enrollment will be based on two stool samples which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days apart. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians. Randomization of participants into the two treatment arms will be stratified according to intensity of infection. Participants will be interviewed before treatment for clinical symptoms and 3 hours after every morning treatment and 24 hours after every morning treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples. The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, two sensitivity analyses will be conducted imputing all missing endpoint data as treatment failures or all as treatment success. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. CRs will be compared by using unadjusted logistic regression. To assess model robustness with respect to covariates, adjusted logistic regressions (adjustment for age, sex, school, weight and strata) will be performed. Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for ERRs and the difference of the ERRs.

NCT ID: NCT03241901 Completed - Malaria,Falciparum Clinical Trials

"Prolonging the Therapeutic Life Span of Artemisinin-based Combination Therapies (ACT) in Bagamoyo District, Tanzania"

ALU-PQ
Start date: July 27, 2017
Phase: Phase 4
Study type: Interventional

This clinical trial evaluates the advantage of prolonging the therapeutic life span of Artemether-lumefantrine from 3 days to 6 days, and addition of single low dose of Primaquine 0.25mg/kg. The study will have two arms, one that will receive standard treatment of uncomplicated malaria with Artemether-lumefantrine, and the other arm will receive the prolonged dose of 6 days together with single low dose primaquine. This approach is expected to provide strategies for malaria control in an era of imminent Plasmodium falciparum resistance.

NCT ID: NCT03227653 Completed - Clinical trials for Medication Adherence

Neuropsychiatric Side Effects of Efavirenz in Children Living With HIV

Start date: June 19, 2017
Phase:
Study type: Observational

Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing evidence shows that central nervous system side-effects in adults are more common than previously thought. Still, reliable data in children are lacking. As HIV-infected children nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential long-term central nervous system side-effects, interfering with neurodevelopment and psychosocial maturation. Using validated tools, we assessed (1) competence (social/activities/school) and psychopathology (internalizing/externalizing problems), (2) cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian children on an efavirenz or non-efavirenz based regimen In this cross-sectional observational study the investigators will examine neuropsychiatric and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination antiretroviral therapy (cART) with or without efavirenz.

NCT ID: NCT03226379 Completed - Clinical trials for Cryptococcal Meningitis

Driving Reduced AIDS-associated Meningo-encephalitis Mortality

DREAMM
Start date: April 23, 2016
Phase: N/A
Study type: Interventional

The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment algorithm and, 4) Communities of practice in infectious diseases and laboratory capacity building) when combined reduce two week all-cause mortality of HIV-associated meningo-encephalitis in African LMICs.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase:
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03215680 Completed - Iodine Deficiency Clinical Trials

Climat Impact on Urinary Iodine Concentration

LION
Start date: July 10, 2017
Phase:
Study type: Observational

Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce urine volume and consequently increase UIC independent of iodine status. This could lead to an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable groups. In this longitudinal observational cohort study in women of reproductive age we will collect 24h and spot urine samples in the summer and winter season. The influence of high temperature climates on UIC, measured and estimated urinary iodine excretion will be estimated.

NCT ID: NCT03208179 Completed - Pregnancy Clinical Trials

Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

IMPROVE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

NCT ID: NCT03141060 Recruiting - HIV Infections Clinical Trials

Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-Infected and HIV-Uninfected Children With MDR-TB

Start date: January 30, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected children with MDR-TB.

NCT ID: NCT03133832 Recruiting - Clinical trials for Schistosomiasis Haematobia

The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium

Start date: April 10, 2017
Phase: Phase 3
Study type: Interventional

Schistosomiasis remains an important parasitic disease in the tropics, special in Africa including Zanzibar. The WHO-recommended strategy to eliminate schistosomiasis involves large-scale treatment of affected populations through periodic, targeted treatment of school-children with praziquantel. Donated praziquantel is the key to achieving elimination. The increase in the number of treatments is attributable to many factors, including improved availability of donated praziquantel, essentially from Merck; new countries starting to implement large-scale schistosomiasis control programmes; geographical scale-up of treatment within countries; and improved reporting to WHO. The global target set by WHO in the Roadmap on neglected tropical diseases is to attain at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. Experience from China demonstrates that preventive chemotherapy (that is, large scale treatment without individual diagnosis) with high coverage can significantly impact indices of infection and reduce transmission. The praziquantel made in China has been used from 1990s, and have effectively activity against S. haematobium, special the good economic benefits. The project will propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of Chinese-made Praziquantel versus WHO Praziquantel in the treatment of 200 people infected with S. haematobium in Pemba island Zanzibar. To do this the investigators will screen about 4000 people by examination of urine for schistosome eggs. Eligible participants will be randomized to receive a single dose of Chinese-made and WHO Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction. The study may provide an alternative drug treatment for S. haematobium.