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Urinary Schistosomiasis Infection

Village Surveys of Morbidity Due to S. Haematobium for 1U01AI4547 Urinary Schistosomiasis-Determinants of Infection and Disease

The purpose of this study is to determine what causes some people to become sick, and others not, when they are infected with the parasite Schistosoma haematobium, also known as Bilharzia. This is an infection of the urinary tract blood vessels and can cause serious disease. Approximately 4400 adults and children of any age will participate in this study. They must be residents of the Msambweni Area, Kwale District, Coast Province, Kenya, where infection with S. haematobium parasites are common. To find out if people are infected, they will first provide 1 or more urine samples for a microscope examination to detect if the S. haematobium parasites are present in the body. Volunteers then will be examined by ultrasound to see if they have kidney or bladder disease. (Ultrasound examination is the use of a non-painful machine that uses sound waves to examine the condition of the internal organs.) Treatment with the drug praziquantel will be offered if S. haematobium infection is found.

調査の概要

詳細な説明

The goal of this project is to focus both field and laboratory research on specific epidemiological, genetic and immunological features that underline the greatest susceptibility to S. haematobium infection and disease. This information, combined with epidemiological modeling of control strategies, will allow accelerated synthesis of the next generation of control programs. The studies in this initial Protocol A involve a large-scale survey of study villages to determine current population demography, general health, infection with S. haematobium, and, specifically, prevalence of parasite-related morbidity. Once evaluated, participants in Protocol A may be subsequently enrolled in Project Protocols B through F if they meet inclusion criteria. The size of the observational Protocol A study cohort (~4,400) is, in part, based on one of its secondary aims: i.e., the need to identify sufficient numbers of morbidity-concordant sibling pairs for genetic studies performed under Protocol D, and sufficient mother-infant pairs for Protocol F. Beyond initial screening, no further investigation occurs in Protocol A per se. Standard doses of praziquantel therapy will be given to treat S. haematobium infection diagnosed under Protocol A. Longitudinal follow-up of a subset of these treated individuals will be performed in Protocols B, C and E of the project. The study will enroll approximately 1100 adults and 1100 children from each of 2 types of rural S. haematobium-endemic village: a) those that have had prior participation in schistosomiasis control programs (1984-1993) and b) those that have not. The Msambweni area of Kwale District in southern Coast Province, Kenya will serve as the 'previously-treated' area. This area has participated in a long-term study of S. haematobium treatment since 1983. Three additional area villages (population ~4,000) that have not previously participated in treatment programs will be included as control 'previously-untreated' areas for comparison purposes to confirm the natural history of untreated infection. Like Msambweni area villages, the comparison villages (Mbuani, Mabakoni, and Gonjora) will be located in southern Kwale District, Coast Province, Kenya. In order to mirror the pre-control experience of the Msambweni villages, comparison villages will be selected primarily for their high S. haematobium prevalence (>40%) as determined in prior Ministry of Health sample surveys in schools. Secondary selection criteria will be village size (1200 to 2000 per village) and a rural, mostly agrarian environment. Residents will update their demography and kinship data, then receive physical examinations, urinalysis, ultrasound and parasitological examinations to determine infection and morbidity status. Because of its size, the population will be surveyed on a systematic, village-by village basis over the first 2 years of the project. These surveys will provide an effective cross-sectional evaluation of current levels of disease in treated and untreated communities at-large. Subjects with suspicion for severe renal dysfunction or bladder cancer (a known late complication of S. haematobium) will be referred to Msambweni or Mombasa Hospitals for further care. The primary study objective is to compare rates of moderate-to-severe urinary tract morbidity associated with S. haematobium infection for older children and adults residing in previously-treated and previously-untreated villages in the endemic southern Kwale District, Coast Province, Kenya. Secondary objectives are to: (1) compare rates of heavy S. haematobium infection for individuals residing in these previously-treated and -untreated villages; and (2) identify eligible subjects for participation in more detailed study of late S. haematobium-related disease, hereditary predisposition to morbidity, association of cytokine response to morbidity, and effects of in utero sensitization to S. haematobium on disease in later life (Protocols B-F of the project).

研究の種類

観察的

入学

4400

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Kilifi、ケニア
        • KEMRI Centre for Geographic Medicine Research

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

99年歳未満 (子、大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Kenyan residents, newborn to adult, either male or female.
  2. Residence in areas of Kwale District endemic for Schistosoma haematobium

Exclusion Criteria:

Pregnancy (this is a partial exclusion). Pregnant women will participate in the parasitological screening phase of the study. However, because of pregnancy-related effects on the urinary system, their ultrasound examinations will be excluded from the analysis of hydronephrosis. Further, because of potential toxicity of praziquantel (Category B) and its alternative, metrifonate (an anticholinesterase), post-protocol anti-parasitic therapy will be delayed until the mother delivers and has stopped breastfeeding her infant.

研究計画

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研究はどのように設計されていますか?

デザインの詳細

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究の完了

2004年11月1日

試験登録日

最初に提出

2005年8月26日

QC基準を満たした最初の提出物

2005年8月26日

最初の投稿 (見積もり)

2005年8月30日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月30日

QC基準を満たした最後の更新が送信されました

2019年1月28日

最終確認日

2007年3月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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