Malaria in PregnancyPhase 3NCT01053325
Establishing Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy
A Phase 3 study testing Cotrimoxazole prophylaxis and SP IPT in people with Malaria in Pregnancy and HIV Infections, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
Trial summary
Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anemia, and is… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria in Pregnancy, HIV Infections
- What is being tested?
- Cotrimoxazole prophylaxis and SP IPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 848 participants
- Where
- 1 siteZambia
- Study dates
- Sep 2010to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed pregnancy (through palpable fundus and/ or positive pregnancy test)
- Gestational age between 16 and 28 weeks
- Hb > 7 g/dl, by Hemocue
- No symptoms consistent with malaria
- Residence within the health facility catchment's area
- Willingness to deliver at the health facility
- Willingness to adhere to all requirements of the study (including HIV-1 voluntary counselling and testing)
- Ability to provide written informed consent. If the woman is a minor of age/not emancipated, the consent must be given by a parent or legal guardian according to national law (however, in this case, also the minor woman will sign the consent form, to document that she is freely giving her assent to take part in the study).
Who cannot join
- History of allergy to study drugs, or previous history of allergy to sulpha drugs
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis
- Any significant illness at the time of screening that requires hospitalization
- Intent to move out of the study's catchment area before delivery or deliver at relative's home out of the catchment's area;
- Prior enrolment in the study or concurrent enrolment in another study
- Severe anaemia (Hb<7 g/dl)
- Previous history of unfavourable pregnancy outcome: pre-eclampsia, caesarean section, stillbirth.
- Eligible HIV-positive women who, following the National guidelines, have to be put on CTX prophylaxis (e.g. having a CD4 count <350/µl) or already on CTX and/or ARV treatment will be excluded from the RCT but included in a prospective observational cohort and receive 2 tablets of CTX daily
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Kabuta Health Centre
Kabuta, Nchelenge District, Luapula Province of
About this study
Official title: A Clinical Trial to Establish The Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy
Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anemia, and is associated with higher risk of low birth weight and perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs, insecticide treated nets (ITNs) and effective treatment of malaria and anemia.
HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women.
Read more
Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in women with ≥200/µl (however, this study was carried out in an area with very low risk of malaria , and CTX may have a different effect depending on endemic conditions). The WHO recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+ patients.
Concurrent administration of SP and CTX may increase the incidence of severe adverse reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient information on the effectiveness of daily CTX for preventing malaria infection in pregnancy: so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase in SP resistance and with the newer antimalarials still being studied for safety and efficacy in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related morbidity and mortality in pregnancy.
This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP in reducing placental parasitaemia. Such information is needed to issue updated, effective guidelines on malaria prevention in pregnancy
Read the detailed description
Malaria is a major contributor of the disease burden in Sub-Saharan Africa: some 90% of global cases occur in Sub-Saharan Africa, with pregnant women and children < 5 representing the most vulnerable population. P.falciparum infection in pregnancy leads to parasite sequestration in the maternal placental vascular space, causing increased risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anaemia; it is also associated with increased risk of low birth weight (LBW) and perinatal, neonatal and infant mortality.In low transmission areas, malaria can be severe with a high risk of maternal and perinatal mortality (up to 60-70%). In highly endemic areas, malaria is still associated with maternal anaemia, LBW and stillbirth. For prevention and control of malaria in pregnancy, the WHO recommends Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and effective case management for malaria and anaemia.
HIV-1 infection in pregnancy increases the risks of malaria. In HIV+ pregnant women, in addition, the efficacy of IPT with sulphadoxine-pyrimethamine (SP) appears decreased.
In Zambia, the malaria incidence rate increased from 121.5/1000 in 1976 to 482.0/1000 in 2003. The high rates were predominantly evident among pregnant women and children <five. Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP.
Several studies in Zambia and Uganda demonstrated that daily cotrimoxazole (CTX) prophylaxis is effective in reducing mortality and morbidity in HIV+ individuals and that antibiotic therapy during pregnancy might impact positively to the reduction of adverse pregnancy outcomes. CTX prophylaxis significantly improves birth outcomes in HIV+ women with CD4<200/µl. A recent study in Zambia concluded that antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in women with ≥200/µl. However, this study was carried out in an area with an extremely low risk of malaria infection; CTX may have had a different impact if malaria transmission was either holo or hyperendemic. Today, WHO recommends daily CTX in addition to ARVs, to prevent opportunistic infections in HIV+, regardless of the background prevalence of CTX microbial resistance.
Concurrent administration of SP and CTX has been associated with increased incidence of severe adverse reactions in HIV+ patients. Therefore, WHO has promoted CTX prophylaxis as an alternative to SP for the IPT in immuno-compromised (CD4 < 350/µl)pregnant women. Unfortunately, there is insufficient information on the effectiveness of daily CTX for preventing malaria infection (placental parasitaemia) and its consequences (maternal anaemia and low birth weight) in pregnancy: so, presently, SP is the only antimalarial treatment for which data on efficacy and safety for IPT is available, and the WHO recommends that at least 2 doses of SP are given after the first trimester. With the documented increase in SP resistance and with the newer antimalarials still being studied for safety and efficacy in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria related morbidity and mortality in pregnancy.
The focus of this study is the malaria related outcome in pregnancy: we will target both HIV negative and HIV positive pregnant women, assuming that CTX is not inferior to SP in reducing placental parasitaemia. Such information is urgently needed in order to issue updated, effective guidelines on intermittent preventive treatment in pregnant women.
An open label clinical trial is the best design to assess the research question and its consequences on the offspring, both in HIV negative pregnant women and in HIV positive pregnant women with CD4 count ≥350/µl. The parallel design was chosen evaluate to each group separately, as HIV might interact with CTX efficacy. Offsets for efficacy were based on literature review.
- Conditions
- Malaria in Pregnancy, HIV Infections
- Being tested
- Cotrimoxazole prophylaxis, SP IPT
- Keywords
- Malaria, Pregnancy, Prevention, HIV, Sub-Sahara Africa
- Medical subject headings
- HIV Infections, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotrimoxazole prophylaxisDrug
Also called CTX, Bacrtim (R)
Daily prophylaxis with cotrimoxazole
SP IPTDrug
Also called SP, Fansidar (R)
Intermittent preventive treatment with sulphadoxine-pyrimethamine
| Study group | Role | What they receive |
|---|---|---|
| CTX in HIV-negative women | Experimental | CTX daily prophylaxis in HIV-negative pregnant women Receives: Drug: Cotrimoxazole prophylaxis |
| CTX in HIV-positive women | Experimental | CTX daily prophylaxis in pregnant women who are infected with HIV Receives: Drug: Cotrimoxazole prophylaxis |
| SP IPT in HIV-negative women | Active comparator | Intermittent Preventive Treatment with SP in HIV-negative pregnant women Receives: Drug: SP IPT |
| IPT SP in HIV-positive women | Active comparator | Intermittent Preventive Treatment with SP in HIV-positive pregnant women Receives: Drug: SP IPT |
| CTX in HIV-positive pregnant women with CD4<350 | Active comparator | Daily prophylaxis with cotrimoxazole in HIV-positive pregnant women with CD4<350 Receives: Drug: Cotrimoxazole prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish that in HIV negative pregnant women co-trimoxazole prophylaxis is non inferior to SP IPT with respect to birth weight at delivery (or within 24 hours). Non inferiority is defined as a difference in mean birth weights of no more than 100g.
Measured: Up to the end of pregancy
Secondary outcomes (4)
To evaluate the effectiveness of co-trimoxazole prophylaxis and SP IPT in reducing placenta malaria in HIV+ pregnant women with CD4 ≥ 350/µl and in the combined group of HIV- and HIV+ pregnant women with CD4 ≥ 350/µl
Measured: Up to the end of pregnancy
To evaluate the effectiveness of CTX and SP IPT in reducing malaria peripheral infection, in HIV negative, and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Measured: Up to the end of pregnancy
To evaluate the effect of CTX and SP IPT on the offspring by measuring the gestational age at delivery, perinatal mortality and birth weight, in HIV negative pregnant women and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Measured: At delivery
To compare the effectiveness and safety profiles of CTX prophylaxis to that of SP IPT, in HIV negative pregnant women and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Measured: Up to the end of pregancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Tropical Diseases Research Centre, Zambia
- Responsible party
- Sponsor
- Investigators
- Christine Manyando, MD, Principal investigator, Tropical Diseases Research Centre, ZambiaUmberto D'Alessandro, MD, PhD, Study director, Insitute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053325
- Sponsor's protocol ID
- ITMP0409
- Status last verified
- Oct 2013
- First submitted
- 18 Jan 2010
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Establish The Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy
- ClinicalTrials.gov ID
- NCT01053325
- Acronym / sponsor ID
- ITMP0409
- Conditions
- Malaria in Pregnancy, HIV Infections
- Keywords
- Malaria, Pregnancy, Prevention, HIV, Sub-Sahara Africa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Tropical Diseases Research Centre, Zambia
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malaria is a major contributor of disease burden in Sub-Saharan Africa: 90% of global cases occur there, and pregnant women and children under 5 years are the most vulnerable. Malaria in pregnancy increases risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anemia, and is associated with higher risk of low birth weight and perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, the WHO recommends Intermittent Preventive Treatment (IPT) with antimalarial drugs, insecticide treated nets (ITNs) and effective treatment of malaria and anemia.
HIV in pregnancy increases the risks of malaria, and it seems that the efficacy of IPT with the drug sulphadoxine-pyrimethamine (SP) is decreased in HIV+ pregnant women.
Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP. Daily prophylaxis with cotrimoxazole (CTX) effectively reduces mortality and morbidity in HIV+ individuals, and antibiotic therapy during pregnancy might help to decrease adverse pregnancy outcomes. CTX prophylaxis improves birth outcomes in HIV+ women with CD4<200/µl: a study concluded that antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in women with ≥200/µl (however, this study was carried out in an area with very low risk of malaria , and CTX may have a different effect depending on endemic conditions). The WHO recommends daily CTX in addition to ARVs, to prevent opportunistic infections in all HIV+ patients.
Concurrent administration of SP and CTX may increase the incidence of severe adverse reactions in HIV+ patients, so WHO has promoted CTX prophylaxis as an alternative to SP for the IPT in immuno-compromised pregnant women. Unfortunately, there is insufficient information on the effectiveness of daily CTX for preventing malaria infection in pregnancy: so, SP is still the only antimalarial recommended by WHO for this purpose. With the increase in SP resistance and with the newer antimalarials still being studied for safety and efficacy in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria-related morbidity and mortality in pregnancy.
This study will try to to see if in HIV- and HIV+ pregnant women, CTX is not inferior to SP in reducing placental parasitaemia. Such information is needed to issue updated, effective guidelines on malaria prevention in pregnancy
Detailed description
Malaria is a major contributor of the disease burden in Sub-Saharan Africa: some 90% of global cases occur in Sub-Saharan Africa, with pregnant women and children < 5 representing the most vulnerable population. P.falciparum infection in pregnancy leads to parasite sequestration in the maternal placental vascular space, causing increased risks of abortion, stillbirth, prematurity, intrauterine growth retardation and maternal anaemia; it is also associated with increased risk of low birth weight (LBW) and perinatal, neonatal and infant mortality.In low transmission areas, malaria can be severe with a high risk of maternal and perinatal mortality (up to 60-70%). In highly endemic areas, malaria is still associated with maternal anaemia, LBW and stillbirth. For prevention and control of malaria in pregnancy, the WHO recommends Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and effective case management for malaria and anaemia.
HIV-1 infection in pregnancy increases the risks of malaria. In HIV+ pregnant women, in addition, the efficacy of IPT with sulphadoxine-pyrimethamine (SP) appears decreased.
In Zambia, the malaria incidence rate increased from 121.5/1000 in 1976 to 482.0/1000 in 2003. The high rates were predominantly evident among pregnant women and children <five. Malaria prevention in pregnancy in Zambia relies on ITNs and IPT with SP.
Several studies in Zambia and Uganda demonstrated that daily cotrimoxazole (CTX) prophylaxis is effective in reducing mortality and morbidity in HIV+ individuals and that antibiotic therapy during pregnancy might impact positively to the reduction of adverse pregnancy outcomes. CTX prophylaxis significantly improves birth outcomes in HIV+ women with CD4<200/µl. A recent study in Zambia concluded that antenatal provision of CTX was beneficial for HIV+ pregnant women with low CD4 but not in women with ≥200/µl. However, this study was carried out in an area with an extremely low risk of malaria infection; CTX may have had a different impact if malaria transmission was either holo or hyperendemic. Today, WHO recommends daily CTX in addition to ARVs, to prevent opportunistic infections in HIV+, regardless of the background prevalence of CTX microbial resistance.
Concurrent administration of SP and CTX has been associated with increased incidence of severe adverse reactions in HIV+ patients. Therefore, WHO has promoted CTX prophylaxis as an alternative to SP for the IPT in immuno-compromised (CD4 < 350/µl)pregnant women. Unfortunately, there is insufficient information on the effectiveness of daily CTX for preventing malaria infection (placental parasitaemia) and its consequences (maternal anaemia and low birth weight) in pregnancy: so, presently, SP is the only antimalarial treatment for which data on efficacy and safety for IPT is available, and the WHO recommends that at least 2 doses of SP are given after the first trimester. With the documented increase in SP resistance and with the newer antimalarials still being studied for safety and efficacy in pregnancy, CTX could be an alternative for SP in reducing malaria and malaria related morbidity and mortality in pregnancy.
The focus of this study is the malaria related outcome in pregnancy: we will target both HIV negative and HIV positive pregnant women, assuming that CTX is not inferior to SP in reducing placental parasitaemia. Such information is urgently needed in order to issue updated, effective guidelines on intermittent preventive treatment in pregnant women.
An open label clinical trial is the best design to assess the research question and its consequences on the offspring, both in HIV negative pregnant women and in HIV positive pregnant women with CD4 count ≥350/µl. The parallel design was chosen evaluate to each group separately, as HIV might interact with CTX efficacy. Offsets for efficacy were based on literature review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CTX in HIV-negative women | Experimental | Drug: Cotrimoxazole prophylaxisCTX daily prophylaxis in HIV-negative pregnant women |
| CTX in HIV-positive women | Experimental | Drug: Cotrimoxazole prophylaxisCTX daily prophylaxis in pregnant women who are infected with HIV |
| SP IPT in HIV-negative women | Active comparator | Drug: SP IPTIntermittent Preventive Treatment with SP in HIV-negative pregnant women |
| IPT SP in HIV-positive women | Active comparator | Drug: SP IPTIntermittent Preventive Treatment with SP in HIV-positive pregnant women |
| CTX in HIV-positive pregnant women with CD4<350 | Active comparator | Drug: Cotrimoxazole prophylaxisDaily prophylaxis with cotrimoxazole in HIV-positive pregnant women with CD4<350 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed pregnancy (through palpable fundus and/ or positive pregnancy test)
- Gestational age between 16 and 28 weeks
- Hb > 7 g/dl, by Hemocue
- No symptoms consistent with malaria
- Residence within the health facility catchment's area
Key exclusion criteria (8 listed)
- History of allergy to study drugs, or previous history of allergy to sulpha drugs
- History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis
- Any significant illness at the time of screening that requires hospitalization
- Intent to move out of the study's catchment area before delivery or deliver at relative's home out of the catchment's area;
- Prior enrolment in the study or concurrent enrolment in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cotrimoxazole prophylaxisAlso: CTX, Bacrtim (R)Daily prophylaxis with cotrimoxazole | Drug | CTX in HIV-negative women, CTX in HIV-positive pregnant women with CD4<350, CTX in HIV-positive women |
| SP IPTAlso: SP, Fansidar (R)Intermittent preventive treatment with sulphadoxine-pyrimethamine | Drug | IPT SP in HIV-positive women, SP IPT in HIV-negative women |
Primary outcome
To establish that in HIV negative pregnant women co-trimoxazole prophylaxis is non inferior to SP IPT with respect to birth weight at delivery (or within 24 hours). Non inferiority is defined as a difference in mean birth weights of no more than 100g.
Time frame: Up to the end of pregancy
4 secondary outcomes
To evaluate the effectiveness of co-trimoxazole prophylaxis and SP IPT in reducing placenta malaria in HIV+ pregnant women with CD4 ≥ 350/µl and in the combined group of HIV- and HIV+ pregnant women with CD4 ≥ 350/µl
Time frame: Up to the end of pregnancy
To evaluate the effectiveness of CTX and SP IPT in reducing malaria peripheral infection, in HIV negative, and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Time frame: Up to the end of pregnancy
To evaluate the effect of CTX and SP IPT on the offspring by measuring the gestational age at delivery, perinatal mortality and birth weight, in HIV negative pregnant women and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Time frame: At delivery
To compare the effectiveness and safety profiles of CTX prophylaxis to that of SP IPT, in HIV negative pregnant women and in HIV positive pregnant women with a CD4 cell count ≥ 350/µl
Time frame: Up to the end of pregancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Manyando, MD principal investigator
Tropical Diseases Research Centre, Zambia
Umberto D'Alessandro, MD, PhD study director
Insitute of Tropical Medicine, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cotrimoxazole prophylaxis and SP IPT in people with Malaria in Pregnancy and HIV Infections, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish that in HIV negative pregnant women co-trimoxazole prophylaxis is non inferior to SP IPT with respect to birth weight at delivery (or within 24 hours). Non inferiority is defined as a difference in mean birth weights of no more than 100g. (time frame: Up to the end of pregancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.