Please select the eligibility criteria that correspond to the clinical trial below.
Title: Research to Programs for Trachoma Elimination: Antibiotic Trial
Brief Summary: Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Niger, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.


Options:
A: Inclusion Criteria:

* All residents residing in the state-teams which are randomly selected for this study.

Exclusion Criteria:

* Pregnant women
* Children under 6 months of age
* All those who are allergic to macrolides or azalides
* Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.
B: Inclusion criteria for communities:

* Communities are located in the target districts and accessible by vehicle
* The community leaders consent to have the community enrolled
* Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
* The community size is \<5,000 persons or \>250 persons.

If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

* The child is age 5 years or younger
* The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
* The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
* The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
* The child must have an identifiable guardian capable of providing consent to participate.
C: Inclusion Criteria:

Communities

* The community location in target district.
* The community leader consents to participation in the trial
* The community's estimated population is between 200-2,000 people.
* The community is not in an urban area.

Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.

Exclusion Criteria:

Individuals

- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
D: Inclusion Criteria:

* Must have been residing in the village for at least three months;
* Must be 90 cm tall or more;
* Must be between 5 years and 65 years of age;
* Must not be pregnant;
* Must not be lactating.

Exclusion Criteria:

* Subjects under 5 years of age or less than 90 cm in height;
* Subjects over 65 years of age;
* Subjects who cannot swallow tablets;
* Subjects who are sick and bedridden;
* Pregnant women (clinical appreciation in the study);
* Lactating women;
* History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole).

Answer: B