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NCT ID: NCT04453124 Completed - Yaws Clinical Trials

An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Start date: November 1, 2019
Phase: Phase 2
Study type: Interventional

In a search for accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. This is an open label clinical trial using an interventional approach, to compare the effect of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

NCT ID: NCT04183322 Completed - Clinical trials for Pneumococcal Infections

PCV13 in Non-pregnant Papua New Guinean Women

Start date: May 10, 2016
Phase:
Study type: Observational

This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.

NCT ID: NCT04124250 Recruiting - Clinical trials for Lymphatic Filariasis Elimination by Mass Drug Administration

East New Britain Province Monitoring & Evaluation

ENBP M&E
Start date: September 17, 2019
Phase:
Study type: Observational

While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020 will be achieved. As of 2016, it was estimated that 856 million people are still living in areas with ongoing transmission of LF and require mass drug administration (MDA) [1]. Of the 52 countries that remain endemic and require MDA, 22 (42%) have not started MDA in all endemic implementation units (IUs) [1]. In addition, several countries have found that, despite completing the required number of treatment rounds, the response to the present MDA regimen has been suboptimal in some IUs, requiring additional rounds of MDA.

NCT ID: NCT04098705 Recruiting - Emergencies Clinical Trials

Emergency Department Triage in a Resource Constrained Setting: Application of the World Health Organization Triage Scale in Regional Papua New Guinea

Start date: August 30, 2019
Phase: N/A
Study type: Interventional

Triage is an important component of emergency care (EC). It aims to sort patients based on the urgency of their condition such that the highest acuity patients are prioritised for assessment and treatment. Grounded in the ethical principles of equity and justice, triage is necessary whenever there is a mismatch between demand for EC and the availability of resources. Globally, a large number of triage scales are in use. These differ in the data required to categorise patients as well as the number of tiers. Developed settings tend to utilise five-tier systems. Little is known about the prevalence of triage in low- and middle-income countries (LMICs), including in the Pacific region. There is also limited evidence about the utility, validity and reliability of triage scales in these contexts. While a landmark study in a paediatric Emergency Department (ED) in Malawi demonstrated that training staff in emergency skills, introducing triage and improving flow substantially reduced case fatality rates, the mortality reduction attributable to triage is unknown. A small number of triage scales have been developed for resource-limited (RL) environments. The most widely studied is the four-tier South African Triage Scale (SATS), which has demonstrated reasonable reliability and validity. In the Pacific region, SATS has provided a foundation for the three-tier Solomon Islands Triage Scale (SITS), which has recently been piloted in Honiara. The World Health Organization (WHO) has also recently released a three-tier triage scale. Neither of these instruments has been validated. Although the potential value of triage systems in resource-limited EDs is increasingly recognised, the current evidence base is limited. The impact on process indicators (eg, time to assessment) and clinical outcomes (eg, mortality) for time-critical conditions is largely unknown. This study aims to address this knowledge gap.

NCT ID: NCT03676140 Completed - Trachoma Clinical Trials

Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately. Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

NCT ID: NCT03664063 Completed - Trauma Clinical Trials

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

Start date: September 1, 2018
Phase: Phase 2
Study type: Interventional

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.

NCT ID: NCT03490123 Completed - Yaws Clinical Trials

Evaluation of an Intensive 3-round MDA Strategy Towards Yaws Eradication

Start date: April 16, 2018
Phase: Phase 4
Study type: Interventional

The current principle of yaws eradication (the Morges strategy) is based on single round mass drug administration (MDA) of azithromycin (AZI) called total community treatment (TCT) followed by targeted treatment of active cases every 6 months to detect and treat cases and contacts called total targeted treatment (TTT). Studies done in Papua New Guinea (PNG) show that 1 round of MDA will probably not suffice to stop transmission of infection. It may be preferable to conduct 3 rounds of MDA prior to the switch to TTT because of high coverage requirements to achieve elimination, particularly of latent cases. The investigators plan to determine whether 3 rounds of MDA are more effective for reaching yaws elimination. This research is needed to guide national programmatic implementation and needs to be done as soon as possible to scale up the program in the country. The aim of this proposal is to ascertain the number of rounds of MDA with AZI to be included in an improved strategy towards yaws eradication. The study will be implemented in 38 wards of New Ireland Province (NIP). The investigators will compare two different distribution strategies of MDA: (A) strategy with 3 biannual rounds of MDA and (B) a single mass treatment round of MDA followed by targeted treatment of cases and contacts. The investigators will also monitor the risk of appearance of antimicrobial resistance in Treponema pertenue.

NCT ID: NCT03352206 Completed - Clinical trials for Lymphatic Filariases

Prevalence Studies After Triple Drug Therapy for Lymphatic Filariasis

Start date: October 18, 2017
Phase:
Study type: Observational

This study will assess the impact of 2-drug (DA) or 3-drug (IDA) regimens on lymphatic filariasis infection parameters in communities. Parameters measured will include: circulating filarial antigenemia (CFA) assessed with the Filariasis Test Strip (FTS), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).

NCT ID: NCT03268252 Completed - Clinical trials for Lymphatic Filariasis

Optimization of MDA With Existing Drug Regimens for LF: Monitoring Efficacy of Ongoing Treatment Programs in PNG

MDA
Start date: June 2012
Phase:
Study type: Observational

The standard regimen for elimination of lymphatic filariasis (LF) in PNG is annual administration of two drugs at the same time. The two drugs are called "DEC" (Diethylcarbamazine, 6 mg/kg body weight) and "ALB" (Albendazole 400 mg for all individuals regardless of weight), which are given one time per year for five to seven years with the aim to interrupt transmission that occurs through local mosquito vectors. These drugs kill the larval forms of the parasite in the blood that are necessary for continuing transmission of infection by the mosquito vector. The two drugs were previously thought to have little effect on adult worms, the stage of the parasite which is responsible for production of the larval forms that appear in the blood of infected people. Recent data, however, suggest that DEC and ALB can kill or render adult worms unable to produce the larval forms (sterilization). Therefore, giving these drugs twice per year for three consecutive years may increase the rate of killing or sterilizing of adults worms over regimens that involve administration of the same drugs only one time per year. The overall goal of this research is to compare the anti-parasite activity of DEC plus ALB given one time per year, the current standard for MDA to eliminate LF, to DEC plus ALB given two times per year (at 6-month intervals) in order to reduce the total duration and cost of MDA to eliminate LF in PNG. Adults (18 years and older) and minors (age 5 to 17 years) will be invited to participate in this study. Study participants will be asked to give finger stick blood samples to check LF infection status and stool samples to determine how well the drugs eliminate intestinal worm infections. Sampling will be done by repeated cross-sectional surveys in the same communities, but not necessarily the same persons, one time per year over a 3-year period. As part of the annual treatment infection surveillance the study team will also collect demographic data (place of residence, family relationship, age, use of bed nets), history of swelling of the arms and legs (elephantiasis), scrotal swelling (hydrocele), acute filarial fever accompanied by extremity swelling, and history of prior treatment for LF.

NCT ID: NCT03246230 Recruiting - Clinical trials for Newborn Vaccine Immunogenicity

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

EPIC-HIPC
Start date: September 6, 2017
Phase: N/A
Study type: Interventional

Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use. To gain insight into how vaccines induce protection of the most vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy & Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV): (a) systems biology that uses technologies which comprehensively measure global changes in molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell composition of the blood and (b) use of human newborn blood components, collected prior to immunization, to model vaccine responses in vitro (outside the body). Characterizing vaccine-induced molecular patterns ("signatures") that correspond to vaccine-mediated protection will accelerate development and optimization of vaccines against early life infections of major global health importance.